Role details

Senior Quality Engineering Manager

Danbury   •  Permanent

Bullet points

  • A leading medical device manufacturing company located near Danbury, CT
  • Hiring a Senior Quality Engineering Manager with prior industry experience

About Our Client

Our client is a market leader in the medical device manufacturing industry located near Danbury, CT.

Job Description

The Senior Quality Engineering Manager will have the following responsibilities:

  • Act as a Quality Lead for the Change Control Program and serve as a technical expert for the electronic change control system. This includes change control review & impact assessment of proposed changes to the validated state of process equipment and medical devices.
  • Other support activities are required such as change control tracking, reporting, and change control meetings to ensure timely closure.
  • Review and approve validation documentation such as Validation Master Plans, Process Validations, Cleaning Validations, Sterility Assurance Validations, and Qualifications that support CMO validation efforts. .
  • Support the Annual Product Review Program for a host of diverse product groups. Host kickoff meetings, prepare schedules, and ensure all APR's are prepared in accordance to company procedures.
  • Represent Quality Engineering in cross-functional corporate projects. Provide updates on validation and change control issues at the project level & escalate to senior management as appropriate. Projects range from implementation of new packaging configurations to product launches.
  • Participate with internal & external audits on as need basis, prepare CMC sections of regulatory filings as well as Annual Reports, attend Quality focused meetings, and prepare Monthly Reports & metrics.

The Successful Applicant

The preferred candidate for the Senior Quality Engineering Manager will have the following background and experience:

Minimum education requirements:

  • Bachelors (Masters preferred)

Experience required:

  • 7 - 10 Years

Knowledge & skills (general and technical):

  • Class III or II medical device experience (catheter experience preferred).
  • 5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
  • Champion statistical techniques, including reliability, to design and process areas. (Minitab or equivalent).
  • Demonstrated performance and results non-conformance management and reduction, value improvement, risk reduction, and cost containment.
  • Strong understanding of risk management in design, manufacturing and post-market surveillance.
  • Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
  • Demonstrated and impactful strong project management and people leadership skills required.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Willingness to relocate and be open to global mobility assignments.
  • Ability to maintain regular and predictable attendance.
  • Lean Six Sigma Black Belt strongly preferred.
  • ASQ Certified Quality Engineer strongly preferred (CQE, CRE).

What's on Offer

Our client offers competitive compensation packages, great benefits and unlimited opportunities to progress your career!

Apply for this job

Click the Apply or LinkedIn button below or contact Ricki Chiem quoting job reference 1213087
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