דרושים Engineer Product Analysis ב-West Pharma ב-United States, Scottsdale

In this role, you will be under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive investigation process lean initiatives, manage communication with internal and external customers, train team members on new devices and assist with coordinating work for the lab technicians.

• Receive, log, and organize all incoming packages, ensuring proper documentation and maintaining order throughout the entire complaint workflow process
• Maintains processes and procedures for receiving handling, storage, and disposition of returned devices according to regulations and company standards.
• Maintains the product analysis lab including supplies, calibration, equipment maintenance, safety adherence, capacity improvements, and access
• Coordinate lean process improvements for device investigations, lab procedures, and daily productivity as needed.
• Communicates with customers regarding product issues and returned devices.
• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
• Promotes teamwork and collaboration between departments to optimize processes and resolve problems.
• Monitor upcoming deadlines and ensure all tasks are assigned and completed on time.
• Demonstrates a “Customer Service” approach to all activities and assignments.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.
• Exhibits regular, reliable, punctual and predictable attendance.
• Complies with site and enterprise safety procedures when handling biohazard materials/components and potent drug compounds.

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in Microsoft excel for the purposes of trending complaint data.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.
• Able to comply with the company’s safety policy at all times.

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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 testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• 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
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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 on-site role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• No min required 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• 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
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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

Senior Engineer, Quality Systems supports and executes the effective development, implementation, and continuity of the Quality Management System (QMS) at a site and business unit level, ensuring compliance with ISO 13485, EUMDR, GxP, and other regulatory requirements. This role encompasses responsibilities such as supporting and managing the CAPA program(s), non-conformance process(es), management review(s), audit(s), document control, etc. Sr. Engineer, Quality Systems collaborates with business leaders to create and maintain efficient quality system programs, driving change management and continuous improvement initiatives. Provide training on quality best practices and utilize ISO 14971 risk management techniques to ensure alignment with quality requirements. As a key communicator, this position demands excellent written and verbal skills to engage confidently across organizational levels. The role requires meticulous documentation practices, adherence to good manufacturing practices, and active participation in continuous improvement projects, ensuring a safe work environment and compliance with company policies and regulatory standards. This is an onsite role based in Scottsdale AZ.

• Contribute to the enhancement of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements.
• Collaborate with departments and sister-sites to set and maintain quality objectives, metrics, and programs.
• Coordinate and prepare critical information for Management Reviews and safeguard key performance metrics (KPIs) within compliance frameworks.
• Manage the non-conformance system to guarantee comprehensive documentation and resolution of incidents.
• Support internal and external audits by regulatory bodies and clients, ensuring compliance with established quality standards.
• Drive effective change management processes at a site and business unit level, assessing product/process modifications against quality requirements.
• Train staff to procedures and quality best practices, fostering an organization-wide quality-centric culture.
• Utilize ISO 14971 risk management techniques to mitigate risks in product development and manufacturing processes.
• Develop and uphold robust procedures for quality system elements per ISO 13485.
• Identify and propose process improvements to enhance quality and operational efficiency.
• Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation and resolution through the CAPA Review Board (CRB).
• Facilitate root cause analysis, implementing CAPA to address quality issues and support continuous improvement initiatives.
• Maintain a high level of scrutiny in reviewing and approving CAPA investigations and extensions.
• Provide detailed reports and insights on QMS performance to senior management.
• Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971.
• Adhere to all regulations, policies, and safety protocols consistently.
• Maintain punctuality and reliable attendance, adhering to a customer service-oriented approach.
• Keep a clean, orderly, and safe working environment.

• Education: Bachelor's Degree in Engineering or Science or equivalent experience required
• Work Experience: 5-8yrs of experience in a Quality Management System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential (medical device manufacturing preferred).
• Proven track record in handling Quality System Procedure(s), CAPA, non-conformance, and audits as part of a QMS. Proficient knowledge of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Regulatory and QMS Knowledge: Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR. Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Skills and Competencies: Strong analytical and problem-solving skills, particularly in non-conformance, CAPA, and root-cause analysis. Excellent organizational skills and the ability to communicate effectively at various levels of the organization. Proficiency in working within a team-oriented environment with strong interpersonal capabilities.

• Technical Proficiency: Demonstrated expertise in computer skills and familiarity with quality-related software and tools including EDMS and SAP.
• Deadline & Project Management: Proven ability to efficiently meet deadlines in a fast-paced, changing environment.
• Problem-Solving Expertise: Strong problem-solving skills with knowledge of Lean Six Sigma methodologies being advantageous.
• Root Cause Analysis: Proficient in Root Cause Analysis methodologies such as A3, 5 Why’s, 6M’s, 8D’s, and DMAIC.
• Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, and GDP.
• Analytical Skills: Strong data analysis skills with knowledge of statistical requirements for sampling plans (application of Minitab statistical software, preferred).
• Organizational Skills: Highly organized, detail-oriented, and self-motivated with project management expertise.
• Communication Skills: Experienced in report writing with clear and effective communication, and experience working with manufacturing operations. Ability to communicate with and to multiple levels and positions within the organization.
• Validation Expertise: Skilled in validation processes and experienced with manufacturing operations.
• Collaborative & Independent Work: Ability to work effectively both individually and as part of a team, with the capability to engage and leverage others to accomplish projects.
• Procedural Awareness: Ability to develop, understand, and adhere to all relevant standard operating procedures as per company policies and regulations related to this role

Certification in Quality Engineering (CQE) or as a Certified Quality Auditor (CQA) is preferred.

In this role, you will work under the direction of the Complaints Quality Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive lean initiatives on the investigation process, manage communication with internal and external customers, and train team members on new devices.

• Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations; such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes.

• Is proficient in the process of conducting root cause investigations of R&D or returned field units.

• Utilizes on the job experience, critical thinking skills, and root cause analysis methodologies to assist lab technicians with atypical and/or complex root cause determination.

• Has effective technical writing skills and is able to communicate findings in a technical, concise, and effective manner with little to no assistance. Documents investigations reports per procedures.

• Assists the Complaints Quality Manager with:

  • Review and approval of investigation reports

  • Training technicians on the investigation processes and use of laboratory equipment.

  • Performing daily, weekly, and/or monthly tracking and trending activities related to complaints and other lab metrics.

  • New customer onboarding

  • Complaint-handling process improvements / lean initiatives.

• Contributes to the design and development of new tests and debugging methods.

• Identifies critical product issues. Assists with Issue Reviews and Corrective & Preventive Actions (CAPAs) when necessary. Contacts appropriate support and/or management to ensure issues are reported and resolved.

• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.

• Facilitates teamwork and collaboration between departments to maximize processes and resolve problems.

• Demonstrates a “Customer Service” approach to all activities and assignments.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Complies with the company’s safety and quality policies at all times; including proper handling of biohazard materials and components.

• Exhibits regular, reliable, punctual and predictable attendance.

• Education: Bachelor's in Science or Engineering

• Experience: 3-5 years of experience

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.

• Demonstrated ability to:
  • Prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (writtenand verbal)

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• No min required 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• 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
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 follow directions, 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