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Senior Quality Engineering Manager
- 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.
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)
- 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!