Senior Quality Design Development Engineer

The Senior Quality Design & Development Engineer will be responsible for overseeing various quality functions particularly focusing on Design Control (product development) Regulatory Compliance and supporting manufacturing processes. This role also involves conducting qualitative and quantitative data analysis complaint investigation training metrology and gage R&R while contributing to strategic quality system initiatives. Collaboration across departments and ensuring adherence to industry standards such as FDA and ISO13485 is critical to this position.

Key Responsibilities:

• Product & Process Qualification:
  Lead the development and of operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
• Risk & Hazard Analysis:
  Assist and initiate the development or update of Failure Modes and Effects Analysis (FMEA) and Hazard Analysis as required by project needs.
• Quality Planning:
  Create and manage Quality Plans for development projects establishing clear inspection and acceptance criteria for incoming inprocess and final product inspections.
• Design Control Documentation:
  Oversee and review Design Control activities ensuring alignment with project requirements for Phase Reviews and Product Verification testing.
• Vendor Audits & Qualifications:
  Conduct vendor audits and manage qualifications to maintain compliance with quality standards and regulatory guidelines.
• Internal Audits & Compliance:
  Manage the internal audit schedule lead audits train internal auditors and assess compliance with FDA ISO13485 and internal Quality System requirements. Investigate findings and report on observations.
• ProblemSolving & Quality Metrics:
  Apply systematic problemsolving techniques to resolve quality issues including Corrective and Preventive Actions (CAPA) Customer Complaint Records (CCR) and Nonconformance Material Reports (NMR). Conduct trending analysis on quality metrics.
• Clean Room Oversight:
  Ensure ISO Class 7 clean room compliance by reviewing and analyzing testing and monitoring reports and providing quality oversight.
• CrossFunctional Collaboration:
  Represent quality engineering in phase reviews and across all stages of product development working closely with R&D Manufacturing and QA teams to ensure quality objectives are met.
• Audits & Continuous Improvement:
  Serve as a key member of the customer and thirdparty audit team potentially leading audit efforts. Ensure a culture of continuous improvement across all quality processes.
• Additional Duties:
  Comply with company quality and safety standards and support other quality functions as assigned. This position is not remote and requires consistent punctual attendance.

Qualifications:

• Education & Experience:
  • Bachelors degree in a STEM engineering discipline (preferred).
  • Minimum of 5 years of relevant experience in a quality engineering role preferably in the medical device industry.
• Technical Skills:
  • Strong understanding of mechanical tool design and manufacturing processes with a preference for medical device experience.
  • Extensive knowledge of medical device QSRs Class II or III device requirements and FDA/cGMP and MDD regulations.
  • Proficiency with ISO13485 regulations and Design Control processes.
• Tools & Methodologies:
  • Demonstrated experience with Quality tools such as FMEA Risk Analysis Statistical Analysis and Gage R&R.
  • Skilled in the use of Microsoft Office for data analysis and report writing.
• Soft Skills:
  • Strong verbal and written communication skills including the ability to write technical reports and present complex information clearly.
  • Effective collaboration across a wide variety of functional teams with minimal guidance.
• Preferred Certification:
  • Certified Quality Engineer (CQE) is preferred.
• Other Requirements:
  • Must be fluent in English both spoken and written.
  • Ability to work onsite fulltime.

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