Quality Engineer II
3 weeks ago
A growing, steady company is looking for a skilled professional for their Quality Engineer II role in Laconia, NH. You’ll help ensure our client develops and produces high-quality medical devices that make a difference in people’s lives. This is a full-time, direct-hire opportunity with excellent benefits effective date of hire and a collaborative, fast-paced environment
- Responsibilities of the Quality Engineer IIDesign and implement policies and procedures for testing and evaluating products/equipment for precision and accuracy
- Provide direction, analysis, and recommendations for product development
- Maintain company compliance with FDA regulations and ISO standards
- Write training material and conduct training sessions on quality control activities
- Participate in external/internal audits
- Lead continuous improvement projects
- Support both internal and external customers
- Perform other related duties as required
- Qualifications of the Quality Engineer II5-10 years of experience in the medical device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
- Quality Engineering certification (CQE) preferred, or equivalent body of knowledge (statistics, SPC, GD&T, sampling)
- BS in engineering, a technical or scientific discipline, or additional experience in lieu of degree
- 3+ years of project management experience, preferably supporting a diverse team
- Experience with FDA and ISO 13485 Certification inspections is a plus
- Computer proficiency including Microsoft Office, Minitab preferred
- Experience with Lean Manufacturing and Six Sigma is a plus
- Attention to detail and organizational skills
- Excellent verbal and written communication, customer service, and interpersonal skills
Please share your resume in confidence for this Quality Engineer II role. We look forward to hearing from you
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