Manufacturing Manager jobs in United States, Pennsylvania, Williamsport

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy

Responsible for providing expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.
• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• The role will also have a dotted line reporting relationship to the Director, Operations, Williamsport to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same
• Maintain a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.
• Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output possible.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS. Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, and audit findings.
• Perform the necessary functions in support of the Williamsport Quality System
  • Designated ISO 13485 Management Representative
  • Designated back-up to QA Supervisor for HACCP Manager and SQF Practitioner.
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Participate in customer, regulatory, and internal audits of the plant; participate in supplier audits and participate as part of the Corporate Cross Site Audit Team.
• Review and assist on the updating of customer specifications. Respond to customer/sales regarding the approval or recommended changes to these specifications and maintain a file of the responses and the specifications.
• Oversees complaint handling, non-conformance management, internal and external audits, and CAPA system to ensure timely and compliant systems. Evaluates and provides for audits of external and internal quality systems and their functions, insuring follow through and corrective actions.
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Other duties as assigned

• Bachelor's Degree in engineering, mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering or equivalent experience required
• Master’s degree preferred

• 10+ Years of job-related experience required in the Medical Device or Pharmaceutical Industry.
• 8+ Years of supervisory experience required.
• 5+ Years of experience working with injection molding processes preferred.
• 5+ Years of experience in an FDA or ISO regulated industry required, preferably in medical device manufacturing.

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines and other relevant regulatory requirements (e.g. HACCP).
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively
• Project Management experience preferred

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy

This role will require you to develop strategic plans for maturing the lean culture and efficiency within the site and West. You’ll provide leadership, influence and team development on lean thinking and lean processes at all levels in the organization. You will distill and work across the site to implement the West Business System. You will govern site lean savings, goals and objectives. You will lead site wide efficiency projects. A strong desire to engage teams across all levels and implement improvements assures that you are a good fit for the role.

• • Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
  • Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
  • Working with site teams identify annual site savings, manage the tracking, validation and communication of savings. Ensuring contingency plans are implemented for at risk projects.
  • Working with the Site Leadership and operations teams develop robust Lean Daily Management systems including leader standard work, Tiered meetings, daily Gemba’s
  • Participate in the development and implementation of the West Business System (WBS) on site, working with stakeholders to sustain and improve operational standards on the site.
  • Organize and embed the Operational Excellence systems (Kaizens, 5S events, Gemba’s, Lean programs, GB/BB projects and certifications, LDMS, Maturity model, Etc.)
  • Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
  • Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
  • Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
  • Manage the continuous improvement of the West Kaizen program.
  • Work with all departments to develop and maintain meaningful lean metrics, status update reporting, and documentation of identified and implemented projects.
  • Work with the relevant stakeholders on new business implementation – facilitating value stream mapping, material flow modelling and layout review.
  • Network, assist and support lean efforts and best practices across the organization through participating in events and sharing of documentation and improvements.
  • Continuous updating and development of lean implementation plans and strategic future stream maps.
  • Other duties as assigned

• Bachelor’s degree in Engineering, Business or Statistics concentration; or recognized equivalent
• Master’s degree is preferred.

• 10+ years’ experience in a manufacturing/production environment
• Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies.
• Medical Device industry experience preferred.

• • Must have good interpersonal/leadership/influential skills and be able to interface with all departments and team member levels.
  • Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
  • Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Work closely with other functions to maximize achievement through a cooperative environment
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification Upon Hire required and
• Health Services\CSSBB - Six Sigma Black Belt Upon Hire preferred

• Safely work in construction environments
• Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI)

• Assist in making necessary repairs and adjustments to machines and systems to ensure highest possible quality while maintaining lowest reject rate possible.
• Follow engineering department guidelines and procedures.
• Assist in performing changeovers and setups on systems and make minor adjustments as necessary.
• Have an understanding operation and set up and be able to maintain repair and a variety of machinery with the assistance of a trainer.
• Learn and perform preventative maintenance as required on schedule.
• Complete necessary production records and requisitions for materials and supplies.
• Interface with lead and purchasing/receiving coordinator with spare parts and material concerns.
• Support process improvement efforts and perform related duties.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Analyzes and resolves work problems and assists workers in solving work problems.
• Participate in validation activities as needed.
• Must observe good housekeeping practices.
• Participate in validation activities as needed.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as required and/or assigned.

• High School Diploma or GED required

• Minimum 3 years of experience in operating drill press, band saws, hand tools and grinding/abrasive tools with a mechanical / electrical background required. Vocational program / Trade School training may be substituted for experience.

• Ability to read mechanical diagrams and schematics.

• Champion a culture of health and safety in accordance with the highest standards of regulatory compliance.
• End to end ownership for the full business value stream.
• Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).
• Support the Customer Account Manager in developing and executing a compelling strategic sales / business plan for the continued growth of the Value Stream
• Commercial leadership and management of Value Stream customers, including full operational P&L responsibility.
• Lead and drive the highest standards in Operational performance, 6S, people development to build on the culture of continuous improvement and growth, to deliver tangibly high quality performance outcomes
• Drive excellent cross functional relationships both within the Value Stream and companywide.
• Demonstrate excellent leadership visibility to drive engagement levels across the organisation.
• Development of the team to support Value Stream and performance and growth, including the recruitment, identification, development and retention of talent in the Value Stream.
• Strong coaching / development of team using development and retention plans as appropriate.
• Other duties assigned.

• Education: Bachelor's in a technical discipline to include: Business, Operations or Engineering.

• Experience: 8-10 years of experience in leading and managing a diverse team in a fast paced and highly regulated environment.
• 3+ years’ experience of working in medical devices sector or similar is an advantage.
• Ideally have injection molding and tooling knowledge / expertise.

• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence and process documents.
• Ability to speak effectively before groups and employees in the organization.
• Write monthly progress reports and capital request.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this job description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs.
• Minimal travel

The Process Engineering Manager will lead the engineering team responsible for developing, optimizing, and maintaining robust injection molding processes for medical device manufacturing. This role requires deep technical expertise in injection molding and process validation within a regulated, high-precision environment. The ideal candidate will ensure compliance with ISO 13485, and GMP requirements, while driving continuous improvement in quality, efficiency, and cost.

• Lead and manage a team of process engineers, process engineering technicians, and validation technicians.
• Develop, validate, and optimize molding processes using scientific molding techniques to ensure high-quality, repeatable manufacturing outcomes.
• Oversee process validation activities (IQ/OQ/PQ) in compliance with ISO 13485 requirements.
• Drive continuous improvement initiatives using Six Sigma, Lean Manufacturing, and other methodologies.
• Interface with Quality and other teams to support new product introductions (NPI) and design for manufacturability (DFM).
• Mentor and develop engineering talent; set performance goals and conduct regular reviews.
• Serve as the primary technical liaison between internal teams and external customers.
• Provide technical support and updates on project timelines, process readiness, and validation status to customers.
• Act as the primary engineering contact for customers during new project development, trials, and production scale-up.
• Review production and operating reports and resolve operational and manufacturing problems to ensure minimum cost and prevent operational delays.
• Develop or revise standard operational and working practices and monitor operations to ensure compliance with standards.
• Support the Sales team with engineering resources to support quoting activities.
• Actively participate and comply with all West HSE and OpEx programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Bachelor’s degree in Mechanical, Plastics, or Manufacturing Engineering.

• Minimum 8 years of experience in injection molding, with at least 3 years in a leadership or management role.
• Proven experience working in the medical device industry with a strong understanding of regulatory requirements (FDA, ISO 13485, GMP) would be an advantage.
• Expertise in scientific molding, process validation, and statistical process control.

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.

• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.
• Knowledge of Lean and 6 Sigma Manufacturing

• Excellent communication skills (in English)
• Ability to assert technical solutions and standards in an international environment
• Ability to collaborate well with people across different countries
• Self-motivated, results- and solution-oriented personality
• Ability to work independently
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

In this role, you will be responsible for performing highly diversified duties to install, troubleshoot, repair and maintain production equipment according to safety, predictive, and productive maintenance systems and processes to support the achievement of the site’s business goals and objectives.

• Provide emergency/unscheduled repairs of all manufacturing equipment during production as well as performing scheduled preventative maintenance of the same.
• Perform mechanic skills including, but not limited to, mechanical, electrical, pneumatic, hydraulic, troubleshooting and repair of production machines.
• Be able to comprehend equipment manuals, electrical wiring diagrams, hydraulic drawings, and mechanical drawings.
• Be able to provide required fabrication of various shields and guards. Ability to bend, cut, shape, weld.
• Diagnose problems, replace or repair parts, test, and adjust.
• Interface with manufacturing engineering to implement process improvements.
• Use a variety of hand and power tools, electric meters and material handling equipment in the performance of your duties.
• Be available to work various shifts, including overtime and weekends when necessary. To share call in duties with others assigned.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 5S program.
• Participate in training to become more proficient in the working knowledge of and repair of incoming machinery.
• Set up and installation of incoming and new equipment.
• Other duties as assigned.

• High School Diploma or GED required;
  • Trade or Vocational School preferred.
  • One (1) year certificate from a technical school or college in a trade relating to electrical, pneumatic or mechanical; or a minimum of 3 years’ experience OJT (related to plant maintenance); or a combination of education and experience in a trade relating to this position.

• 3 years experience; preferably in a Manufacturing setting

• Ability to operate a Powered Industrial Truck.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target