I am representing an innovative Medical Device organization based in MA to secure a Senior Design Quality Manager.
The Senior Design Quality Manager will have additional responsibility for Post Market Surveillance and ultimately be responsible for leading both functions in support of R&D and post market activities and play an integral role in the strategic transformation of the group.
- Responsible to ensure documentation, reports, tests, and results in support of regulatory filings meet the requirements.
- Provide guidance on device clinical trials.
- Provide input on operating procedures and product specifications in conjunction with R&D and Operations.
- Represent Design Assurance in design control activities to ensure compliance to procedures, regulations, and standards. Provide guidance for design and development planning, risk management, and design verification and validation.
- Act as the Senior Design Assurance representative for escalation issues for all Design Assurance and post market activities.
- Represents as required the Design Assurance and Clinical function in the evaluation of new product opportunities internally and externally.
- Provide leadership and guidance to design and development teams in support of qualification and validation activities.
- Manages a budget for resource needs for all initiatives.
- Leads or plays a key role on internal Company governance committees.
- Relationship management and constructive partnering with internal design and development teams and other internal/external customers.
Key Experience Required:
- BS/BA Degree in a Scientific Discipline or combination of education and relevant work experience
- 15+ years medical device Design Assurance/Quality Engineering experience in a managerial role.
- Proven ability to establish and develop design assurance teams through hands on teaching, mentoring and leadership.
- Must have previous experience interacting with ISO, FDA and other regulatory agencies
- Knowledge of FDA Quality System Regulation (21 CFR 820), ISO 13485, Medical Device Reporting Regulations (21 CFR 803, 806), ISO14971, IEC 60601, IEC 62304, and other applicable USFDA and EUMDD regulations ISO 13485.
Sthree US is acting as an Employment Business in relation to this vacancy.