Senior Quality Engineer (Wayne, NJ) Defined Term

Getinge Group-posted 10 months ago
$100,000 - $115,000/Yr
Senior
Wayne, NJ
Miscellaneous Manufacturing
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The Senior Quality Engineer is responsible for effective establishment and maintenance of quality systems. Leads efforts to sustain and enhance Quality Compliance, maintenance of quality systems, preparation/revision of QMS Procedures to sustain compliance. This position is a Defined Term position for a period of one year. Work location is Wayne, NJ where the position is 4 days a week onsite.

  • Review Quality Manual to identify potential gaps in documented quality processes (including outsourced processes), procedures to ensure compliance to ISO13485:2016, MDSAP, and FDA Medical Device Regulations as applicable to CAHW, CADI, and Collagen businesses.
  • Organize existing QMS procedures per QMS documentation hierarchy and ISO 13485:2016 Clause classifications to identify gaps and redundancies, as appropriate.
  • Understand existing Quality Management System processes and procedures, identify improvement/simplification opportunities, and revise quality process / procedures to improve QMS effectiveness and efficiency.
  • Compare and assess QMS procedures for similar processes in CAHW, CADI, and Collagen businesses and identify opportunity to synergize/integrate associated QMS procedures with goal to create effective and unified Quality Management System for Cardiac Assist Business.
  • Collaborate with Corporate Quality Team to understand expectation and plan to align with GETQMS initiative.
  • Revise (create, modify, combine, obsolete) Quality Manual, QMS procedures to create an effective, efficient, and lean set of Quality Management System procedures addressing CADI, CAHW, and Collagen businesses.
  • Review Quality System documents and records storage and archival practices (adobe signed documents and localized archival practices) to identify potential compliance gaps and make necessary changes to ensure compliance with ISO 13485 Document Control and retention requirements.
  • Communicate, interact and coordinate quality improvement efforts with Manufacturing, QA, R&D, and engineering management.
  • Identify and lead implementation of new opportunities for improvements to work processes, and other areas as identified.
  • A bachelor's degree in engineering, Science or equivalent is required.
  • A Master of Science in Engineering, Science or equivalent is preferred.
  • CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
  • A minimum of 5 years with specific hand on experience in creation/sustenance of ISO13495 certified Quality Management Systems along with experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years of above-mentioned experience is required.
  • Prior experience working in an FDA regulated medical device organization or ISO 13485 certified organization.
  • Must have demonstrated proficiency in working with ISO 13485 or 21CFR820 based M Quality Management Systems and Medical Device Regulations.
  • Project management and leadership experience is required.
  • Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.
  • Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
  • Experience in 6σ Methodologies (Lean 6σ, DMAIC, DMADV) will be a strong plus.
  • Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications is preferred.
  • Working knowledge of statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
  • Familiarity with analytical software applications.
  • Base salary of $100,000 to $115,000 a year.
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