Quality Engineer II – Exempt

We are seeking a dedicated and skilled Quality Engineer to join our team in North Haven, CT.

This role offers the opportunity to work onsite, providing quality engineering support for the AMCOR Packaging Project. If you are passionate about quality standards and protocol in the medical device industry, we encourage you to apply.
Must Have

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging, and Laboratory Equipment
• Technical experience (Troubleshooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices

• CAPA investigator
• CAPA Specialist

The responsibilities may include, but are not limited to:

• Developing, modifying, applying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials products.
• Collaborating with engineering and manufacturing functions to ensure quality standards are in place.
• Devising and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designing or specifying inspection and testing mechanisms and equipment; conducting quality assurance tests; and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensuring that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Specializing in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

• Process Validation
• Root Cause Analysis (CAPA, NCMR)
• Statistical Analysis (Process Capability)

• BS degree required
• 2-3 years of relevant experience

This is a full-time position requiring 40 hours per week, onsite in North Haven, CT.

Product Line Support:
This role will support Sutures Finished Goods across multiple product lines.

Timeline for Interviews:
We are looking to schedule interviews as soon as possible.

Lance Soft