What are the responsibilities and job description for the Quality Assurance Engineer position at NESC Staffing?
**U.S. Citizenship Required**
**No Corp to Corp**
The Global Lead - Design Quality Assurance Engineer will be a multi-site leader overseeing the engineering support required for all new product development and lifecycle management projects.
This position will support a global deployment of design control procedures and ensure that projects are adequately staffed to achieve required milestones. This individual will collaborate and partner with peers and senior leadership in other organizations, including Research & Development, Regulatory, Marketing, Supply Chain, and Manufacturing Operations. This role will also be required to support different aspects of the QMS, including quality systems, post-market surveillance, and supplier quality.
RESPONSIBILITIES:
- Lead Design Assurance teams across multiple sites on product development and sustaining engineering projects of significant magnitude and scope. Provide guidance and training to staff, help identify and achieve career goals, motivate individuals to achieve results, and recruit/maintain a high-quality staff.
- Derive and implement department strategies; seek innovative approaches to attaining product performance goals.
- Develop, deploy, and maintain state-of-the-art Design Controls and Risk Management procedures. Provide training and support to increase global understanding of requirements to achieve compliance.
- Collaborate with other leaders in the Quality organization to drive the maturation of QMS procedures. Provide support during Audits, Complaint Review Boards, CAPA Review Boards, etc.
- Establish and maintain positive cross-functional working relationships to help further advance the Quality culture and drive Quality as an advantage.
- Provide significant guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues.
- EU MDR remediation support
- Responsible for risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation, and verification of effectiveness.
- Responsible for quality design transfer activities, including test method validation/measurement systems analysis and incoming inspection. Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
- Responsible for developing and releasing engineering design documentation, supporting the core team during design reviews, and supporting design history file compilation/audit activities.
- Provide quality input to product user needs, design inputs, design specifications, and design outputs (including analysis/definition of critical to-quality features).
- Support design verification testing, design validation, and usability testing.
- Assists in preparation for regulatory submissions and supports sustaining quality by defending design control elements during internal and external audits. Includes leading design control gap assessments (DHF audits).
- Assist in identifying and implementing process improvement initiatives requiring cross-functional and multi-site collaboration.
- This role will also be required to support other aspects of the QMS, including Quality Systems, Post Market Surveillance, and Supplier Quality.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- In-depth familiarity with the FDA, ISO, MDD/MDR, and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- A detailed understanding and working knowledge of US and International regulations, including 21CFR820, 803, 50, and 11, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366, is required.
- Strong communication and presentation skills.
- Competent with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- 8 years of medical device engineering experience
- 1 years of leading engineering teams
- BS in Mechanical, Electrical, or Biomedical Engineering
