What are the responsibilities and job description for the Senior Quality Engineer position at Redbock - an NES Fircroft company?
Sr. Quality Engineer (12-month contract // North Haven, CT):
Top 3 Required Skills:
- Quality Systems & Change Management: Strong experience with medical device quality systems, including change control, document control, nonconformance/CAPA processes, and quality record approval in compliance with ISO 13485 requirements.
- PLM / Digital Quality Systems Implementation: Hands‑on experience supporting PLM or electronic quality systems (e.g., Windchill, Teamcenter, Agile, eQMS), including workflow review, data migration support, system validation activities, and user adoption.
- Cross‑Functional Quality Execution: Proven ability to partner with Manufacturing, Engineering, Regulatory, and IT to assess quality impacts of system or process changes, support audits, and ensure continuity of site Quality operations.
Education Required: BS in Engineering (preferred) or Science
Years’ Experience Required: 5-7 years of combined Medical Device and other regulated industry quality engineering experience
Description:
The Senior Quality Engineer will support the site’s transition to a new PLM system, ensuring quality system requirements, design controls, and compliance expectations are appropriately integrated and maintained throughout the implementation. Day‑to‑day responsibilities include partnering with cross‑functional teams (Quality, R&D, Manufacturing, Regulatory, IT), reviewing and approving PLM-related workflows and documentation, supporting validation and risk activities, and ensuring continuity of Quality operations during the transition. The role may also help offload routine Quality Engineering activities across the site to maintain operational stability.
Duties:
- Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Salary : $55 - $65