Quality Assurance 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

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)

Schedule-12 hour night shift 5:45p-6am

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

• Review and approval of metrology reports, where appropriate, for batch release and validation purposes
• New product validation, analysis and reporting.
• Quality support to Engineering and Production Departments.
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
• Liaise with customers and suppliers on new and existing projects.
• Receiving and inspection of incoming goods and materials.
• Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
• Maintain good communications both internally and externally.
• Ensures that all metrology equipment is correctly calibrated.
• Assists shift personnel with quality issues and/or measurement techniques.
• Assists in problem resolution with customers.
• Perform periodic audits as requested and completes necessary documentation.
• Archives quality records, samples and log procedures.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Batch paperwork review and final decision to release product for shipment.

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

• High School Diploma or GED Required.
• Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment

• 3 years of job-related experience; in QA/QC and the use of measuring equipment.

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions

Schedule- 12 hour day shift

In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.

• Review and approval of metrology reports, where appropriate, for batch release and validation purposes
• New product validation, analysis and reporting.
• Quality support to Engineering and Production Departments.
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
• Liaise with customers and suppliers on new and existing projects.
• Receiving and inspection of incoming goods and materials.
• Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
• Maintain good communications both internally and externally.
• Ensures that all metrology equipment is correctly calibrated.
• Assists shift personnel with quality issues and/or measurement techniques.
• Assists in problem resolution with customers.
• Perform periodic audits as requested and completes necessary documentation.
• Archives quality records, samples and log procedures.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Batch paperwork review and final decision to release product for shipment.

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

• High School Diploma or GED Required
• Preferred Associates degree in Metrology or QA; or 3 years’ on the job experience in a plastics manufacturing environment

• 3 years of job-related experience; in QA/QC and the use of measuring equipment.

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• 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.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions