: Senior Quality Engineer – Biopharma (JP8025)
Location: Thpousand Oaks, Ca
Final Product Technologies Quality
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our client, a leading global bio-pharmaceutical company.
- Provide quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments.
- Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments.
- The role of the Senior Quality Engineer is to provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities.
- Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development; Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
- Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
- Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
- Provide comprehensive quality guidance and advice to counterparts and stakeholders.
Top Must have Skill Sets:
- BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
- 8 years current experience with engineering processes/procedures and quality tools.
- VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, Quality Engineering, AND/OR Systems/Software Engineering background need apply and will be considered!
- Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
- Experience with Automated Test Equipment (ATE)
- Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting.
- Strong critical thinking, problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- Familiarity with the following standards: o Quality System Regulation – 21CFR820; Risk Management – EN/ISO 14971; EU Medical Device requirements – Council Directive 93/42/EEC; Medical Electrical Equipment – EN/ISO 60601
- CAPA and nonconformance experience a must.
- Test Method Validation / Measurement Systems Analysis / GRR.
- Test Method Design and Development.
- Design Controls is preferred.
Employee Value Proposition:
- Oversight and advising of method development/qualification/validation transfer strategies, activities, and deliverables as needed.
- Quality review and approval of relevant deliverables for method development and lifecycle management.
- Support Root Cause, Nonconformance, and CAPA investigations.
- Oversee and advise Nonconformance and CAPA resolution.
Work that the team does ensures maximizes the value brought to patients and shareholders by supporting the development implementation and improvement of robust and reliable test and inspection methods. The staff will be helping Amgen generate better data to make better decision
- No Gauge R&R or MSA experience.
- No Quality Experience.
- No Medical Device/Combination Product Experience.
Phone screen w/ hiring manager, phone interview w/ development quality/commercial quality/engineering stakeholders (min 3 / max 5 persons in addition to hiring manager).
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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