Sr Quality Engineer
The Sr Quality Engineer Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development. of combination and non-combination products.
Ensures that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Manages low to moderate complexity programs with minimal supervision. Provides input on proper quality resource balancing on project(s) as required.
Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the design and development lifecycle, including content from suppliers and partners. Participates in development of final product requirements. Approves device components and final product or the device constituent of a combination product specification as part of development program.
Establishes the quality requirements for development process to transfer design. Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design control investigations on an as needed basis.
Participates in creation, updating, and maintenance of Traceability Matrix. Develops and maintains final product quality plan. Quality approval at all key design phases (i.e., verification, validation, development, and launch readiness) and key participant at design reviews. Quality approver of the Design History File.
Ensures that all Quality Requirements have been met and DHF is ready for Prior Approval Inspections (PAIs), Inspection Readiness Activites, and Partner Audits. Responsible to assemble documentation needed for inspections. Ensures control strategies have been established, implemented, and maintained throughout the design and development lifecycle.
Supports development of program-related quality agreements. Participates in generation of development agreements with third parties.
This position reports to the Director Development Quality, FPTQ and is Advisor to Innovation Quality Lead in FPTQ, Advisor to Commercial Quality Lead and Liaison with FPTQ Commercial. Advisor to Medical Information regarding instructional material interfaces with end user, aligns with Attribute Sciences PD on analytical methods
Advises Marketing on quality aspects of training and demo systems. Is Advisor to Product Complaints, Advisor to PQL/GOL/GPO and Advisor to CPTL/DPTL/STL/DTL.
- Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies activities.
- Attend development program meetings as required as part of program working teams. Work cross-functionally with individuals and project teams to ensure success of development project efforts. Provide guidance on documentation structures created during development activities. Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and Amgen Procedures.
- Provide input to the Design and Development Plans for projects, and review and approve relevant final product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocls and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
- Actively participate and contribute to applicable Design Control Phase Design Reviews. Also provide Quality oversight of Design Characterization and Verification and Validation activities. Ensure adherence to all relevant regulations and standards based on the type of device under development.
- Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
- Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses. Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence for associated projects.
- Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s). Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.
- Doctorate degree OR
- Masters degree and 3 years of Quality experience OR
- Bachelors degree and 5 years of Quality experience
- 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
- Bachelors Degree in a Science Field
- Ability to oversee multiple medium complexity projects simultaneously
- Working knowledge of quality engineering and/or mechanical engineering
- Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
- Prior experience working as part of a combination product launch team
- Able to successfully manage workload to timelines
- Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving decision making by using DAI principles
- Understanding of industry requirements/expectations of a QMS
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations
- Comfortable with both drug and device terminology
- Ability to travel +/- 15-20% of time to domestic and international Amgen sites
- Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
- Combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls
- Knowledge of quality engineering and device engineering
- Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
- Strong problem solving, trouble shooting, and analytical skills
- Advanced technical writing skills
- Able to balance complexity between innovation and regulation
- Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
- Constructively progress to outcomes despite uncertainty or ambiguity
- Drive change, efficiency, and strong cross-functional relationships
- Excellent verbal and written communication
- Lead and motivate a team
- Ability to drive continuous improvements Technical writing
- Critical thinking
- Global mindset
- Situational analysis and reporting
- Process improvement focus(CI / Lean)
- Solution identification
- Provides Quality oversight to final product development activities and deliverables (A)
- Quality approval of project related design control documents (D)
- Quality approver and/or author for Quality Plan (D)
Advises PDT and/or technical team in collaboration with PQL on level of risk for phase specific development activities (A)
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.