Quality Engineer I - Exempt
Lancesoft
North Haven, CT
Join our team in North Haven, CT, a vibrant community offering a perfect blend of suburban charm and easy access to urban amenities. As a key member of our design quality team for Sutures & Polymers, you will play a crucial role in maintaining and enhancing our quality and reliability standards. This position requires on-site work at least four days a week.
Responsibilities
- Assess design, manufacturing, process, and supplier changes.
- Review validation and verification documentation and provide feedback.
- Perform Design Failure Modes Effect Analysis (DFMEA).
- Complete risk assessments for proposed changes.
- Perform and support root cause analysis for product complaints.
- Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Design or specify inspection and testing mechanisms and equipment;conduct quality assurance tests;and perform statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.
- Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
0-2 years of experience required, with skills including but not limited to communication, critical thinking, collaboration, and attention to detail.
Preferred Qualifications
- Experience in the medical device industry or another highly regulated environment.
- Working knowledge of quality systems, risk management, and design controls.
- Strong written and verbal communication skills, including technical writing.
- Experience supporting released medical device products.
- Hands-on experience with DFMEA, risk management files, and design change quality reviews.
- Knowledge of medical device lifecycle requirements, including design, manufacturing, distribution, and obsolescence.
- Experience collaborating with cross-functional teams to resolve quality issues and implement process improvements.
- Familiarity with continuous improvement methodologies and root cause analysis techniques.
Work hours are approximately 9am-5pm EST. The interview process will involve one video call (Microsoft Teams) with behavioral-based questions.
About the Company
Lancesoft
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.