Sr Quality Engineer

Planet Pharma; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare company in North Haven, CT, is looking for a Senior Quality Engineer to support the transition to a new PLM system while ensuring compliance with quality standards. This role involves collaboration with cross-functional teams, reviewing workflows, and maintaining quality operations during the transition. Candidates should have 5-7 years of relevant experience and a degree in Engineering or Science. The position offers a chance to work independently and lead projects ensuring robust quality system integration.

Qualifications

• 5-7 years of experience in quality engineering, flexible based on work history.
• Advanced knowledge of medical device quality systems.
• Experience with PLM or electronic quality systems.

Responsibilities

• Develop quality standards and protocols for processing materials.
• Collaborate with engineering and manufacturing to ensure quality.
• Implement inspection and testing methods for products.
• Conduct quality assurance tests and statistical analysis.
• Ensure corrective measures meet reliability standards.
• Support site transition to a new PLM system.

Skills

Quality Systems & Change Management

PLM / Digital Quality Systems Implementation

Cross-Functional Quality Execution

Education

BS in Engineering or Science

Job 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.

Top 3 Technical 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 of Experience Required

5-7 (flexible given work history)

Responsibilities

• 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.
• Supports the site’s transition to a new PLM system, ensuring integration and maintenance of quality system requirements, design controls, and compliance expectations throughout the implementation.
• Partners 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.
• Helps offload routine Quality Engineering activities across the site to maintain operational stability.

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 and 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 work group 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 indepth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
• Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review to others' work product.
• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.