Sr Quality Engineer - Exempt

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.

Top 3 Technical Skills Required for the Role:

• 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 and Experience:

• BS in Engineering (preferred) or Science.
• 5-7 years of experience (flexible given work history).

Work Schedule and Location:

This position requires a commitment of 40 hours per week and is based on-site 100% at our North Haven, CT location, offering a dynamic work environment in a vibrant community. Flexibility is provided as needed.

Responsibilities:

Responsibilities may include the following and other duties may be assigned:

• Develops, modifies, applies, and maintains quality standards and protocols 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.

Specialist Career Stream:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of workgroup objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
• Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience:

Requires advanced knowledge of the job area, combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.