Manager, NPD Quality Engineer

Locations:
Ft. Lauderdale, FL

Applicants: Click here to apply
 


Job Description:

This position will lead and manage a team of Quality personnel (i.e. QA Engineers, QA Specialists, etc) in the area of New Product Development. This individual will focus on the development of the NPD QE team, with direct responsibilities in hiring, developing, and performance managing those within the team. Leadership within the QA Department is required, not just within the department but also to the Engineering department.The QE Manager for NPD will be required to regularly communicate and meet the needs of the NPD engineering teams within the quality role. Focused responsibilities in Risk Analysis and Mitigation and the Verification and Validation Process are a priority, as well as complete ownership and continuous improvement in the Quality System processes specific to Design Controls. When necessary, the QE Manager, NPD, will be required to be directly involved in project deliverables as well as delegating and leading those same responsibilities through their team.This person will work closely with the Director of Quality on team development both in growth and performance management, delivering on commitments and responsibilities within the NPD engineering teams and projects, and supporting the Design Control processes of the Quality System. They will also provide front line support in meeting the requirements of to 21 CFR Part 820 Subpart C - Design Controls, as ISO 13485:2003 Section 7, and supporting auditing of those sections both internally and by external parties.

Responsibilities:

• Identify NPD QA talent and manage team personnel. Set clear and concise expectations for the team, measure performance to those expectations, hold individuals (including themselves) accountable to performance, and communicate this information to superiors.
• Provide leadership and coaching to NPD QA team, and also provide a clear communication channel to both the team members and the Director of QA.
• With support from Director of QA, develop, track, and communicate business objectives for the NPD QA Team that contributes to meeting the business objectives of the QA Department.
• Support, both indirectly through leadership and directly when circumstances require, all functions of the NPD QA team personnel. These areas include (but are not limited to): risk analysis / mitigation strategies, design control processing and investigation, quality system improvements with the Design Control functions, print and procedure reviews, audit support (both internal and external), etc.
• Provide information, presentations, data, etc. to upper management on Quality issues within the NPD process. This includes but is not limited to Management Reviews, departmental meetings, company meetings, etc.
• Provide positive input and guidance in developing a culture of compliance to the Quality System, but interfacing at a managerial level with NPD teams.
• Identify and implement process and procedural changes within the Design Controls section of the Quality System in order to improve compliance and/or improve efficiency of the NPD process.
• Functions, CAPA activities, complaint

• BSME, BSEE, BSBME preferred.
• Masters degree in a related field is a plus.
• Minimum 5 years of engineering experience in NPD for Medical Device Company.
• Minimum 3 years experience in supervising / managing engineers. Significant evidence of strong leadership required. Strong verbal and interpersonal skills. Ability to inspire and lead a team of QA individuals and maintain personnel engagement both within the team and with those teams that interface with the QA Department.
• Extensive knowledge of to 21 CFR Part 820 and ISO 13485 sections relating specifically to Design Control. Knowledge of other areas of 21 CFR Part 820 and ISO13485 and experience with medical devices is preferred.
• Extensive knowledge of ISO 14971 and implementation of a risk and hazard analysis process.
• American Society for Quality, Certified Quality Engineer (CQE) preferred.
• American Society for Quality, Certified Reliability Engineer (CRE) is a plus.