Location: Brookfield, CT
Employment: Full time
We are currently seeking an exceptional Director of Quality for immediate hire, to work on-site, in our headquarters at Brookfield, Connecticut.
Duties and Responsibilities
- Develop and maintain all aspects of the quality system
- Ensure compliance to the Quality Manual and FDA QSR regulations, while also assisting to obtain ISO 13485 certification
- Develop and continuously update the company’s Quality Policy, Quality Manual, Standard Operating Procedures (SOPs) and quality records
- Monitor design and development activities and records for compliance to procedures
- Ensure timely release of Quality records (ECN processing, obtaining signatures from third party reviewers)
- Ensure timely archival of hard copy final quality records
- Schedule Management Reviews, define agenda and capture meeting minutes
- Manage the internal quality auditing process (scheduling, follow up)
- Schedule and participate in vendor qualification activities
- Follow up on corrective action following Supplier Audits
- Help develop response to external audits
- Assist with risk management activities
- Interface with Regulatory personnel, to ensure applicable regulatory requirements are met. Drive continuous improvement activities through the collection and analysis of data
- Manage complaint handling (post market)
- Manage the CAPA process
- Assure integration of quality objectives into manufacturing objectives at the third-party contract vendor, while helping drive early defect identification
- Lead QC efforts in routine review and approval of Manufacturing records at contract third party manufacturer
- Compile and provide statistical analysis and support quality data for management reviews
- Interact with all ROMTech departments to achieve these goals
- Timeliness of coordinating and release of final documents following notification of finalization of documents (DHF, DMR)
- Feedback from Internal/external audits. i.e., review of completeness of Document Control records
- CAPA Status – exercising of the CAPA system, review of CAPA closure
- Review of trends on company metrics, i.e., processing of presentations towards and scheduling of management Reviews
- Review of internal and external audit
- 10+ years of experience as a Quality Director or Manager in the medical device industry
- Strong working knowledge of ISO 13485, FDA Regulation 21 CFR Part 820 (QSR), MDD/MDR
- Excellent interpersonal skills; strong written and oral communication skills
- BS degree in technical discipline (Mechanical, Electrical Engineering or other relevant discipline).
This crucial position in the company is a great opportunity for someone who wants to roll up their sleeves, build a team and make a difference. We seek a positive and solution-conscious individual who can hit the ground running.
Qualified candidates, please respond and include:
- A cover letter detailing why you are the ideal fit for this job
- An up-to-date resume
Candidates who send resumes without the requested cover letter will not be considered.
Finally, openness, honesty, and candidness are qualities we respond to—as opposed to framing things in the right way with the right words. Please be who you are and let the dice roll.