Collabera Project Engineer/Quality Engineer in Whitehouse Station, New Jersey
Project Engineer/Quality Engineer
Location:Whitehouse Station, New JerseyUS
• Actively represent Device Quality function on commercial value streams and/or product/core development teams.
• Participates on teams supporting development of combination products and oversight of quality issues related to pure medical devices and the device constituent of a combination product.
• Audits and approves Design Control and Device Risk Management documentation for applicable regulatory filings, clinical supply, development and design transfers.Ensure compliance with regulatory and requirements. Evaluate deficiencies and assess impact on compliance status.
• Provide guidance to Packaging Commercialization or Device Development personnel to ensure Quality by Design, design control tools, and internal SOPs are implemented in an effective manner, including best practices for systems engineering or reliability.
• Lead or participate in design reviews to ensure adequate design control readiness and compliance.
• Hands on participant in early stages of product development including but not limited to product conceptualization, engineering/development, competitive, and prototype testing.
• Drafts quality plan, and validation master plans that encompass the life-cycle and risk-based approach of development and sustaining activities.
• Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Provide input to design house experts to review material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
A minimum of a Bachelor’s degree in Science or Engineering or associated fields with a minimum of Five (5) years with BS or three (3) years or more experience or MS with 1yrs experience with Ph.D., with emphasis in Quality Engineering, Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, or medical device industry (or related industry), or experience in related engineering/Scientific areas, e.g. R&D or Manufacturing. Advanced degrees may be used reduce required experience.
• Design controls, purchasing controls, process controls.
• Risk analysis (ICH Q9 and/or ISO 14971)
• Medical Devices (ISO 13485, 9001, IEC 62304, 92/43EEC))
• Applied statistical techniques (t-test, ANOVA, etc)
• Design of experiments, Root cause analysis and/or Problem solving techniques.
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); project management principles; and ICH Q8, Q9, and Q10 procedures is desirable.
Knowledge of medical device regulations QSR (21CFR part 820s), and compliance in a specialized area with experience in their application, including current GMPs for combination products (21CFR part 4).
• Demonstrated ability to work collaboratively in cross functional teams and networks. Working knowledge of technical aspects of device development and commercialization. Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.
• Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) or Certified Biomedical Auditor (CBA) is strongly desired.
• High proficiency with MS Word, MS Excel, Power Point and statistical tools (e.g., Minitab or Sigma XL) is required. Strong documentation skills are required.
• The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must have excellent communication and interpersonal relationship skills.
Minimal travel domestically and internationally (<15%) may be required.