Summary:
A leading contract manufacturing firm based in Minneapolis, MN, is searching for a Senior New Product Introduction (NPI) Quality Engineer with extensive experience to join their dynamic team during this crucial stage of their expansion.
In this role, you will play a vital role within their New Product Introduction Quality Engineering team, offering invaluable assistance to both their development and manufacturing sectors.
Your duties will involve providing thorough quality engineering assistance to their development and manufacturing teams, with a particular focus on the transfer of product and process designs.
Responsibilities:
- Provide comprehensive quality engineering support to development and manufacturing teams, focusing particularly on product and process design transfers.
- Engage in various activities including facilitating new product launches, overseeing site/process expansions, managing product/process modifications, and driving strategic manufacturing-led initiatives, including international expansions.
- Actively serve as the Quality representative for projects within the scope of this role.
- Collaborate with Design Quality Engineering to ensure successful product transfer into manufacturing.
- Apply engineering principles and quality regulations to drive validation and qualification executions during transfer phases for new product introductions and ongoing design control projects, including reviewing and approving protocols.
- Oversee execution for IQ/OQ/PQs, TMVs, engineering studies, and verifications.
- Utilize statistical knowledge to complete and analyze datasets, interpret results, and offer data-driven feedback to design and manufacturing teams.
- Participate in the development and continuous improvement of applicable procedures to ensure compliance with standards and industry practices.
- Generate technical reports to support quality assurance investigations as required.
- Act as the NPI quality representative for associated risk documentation.
Education, Experience, Skills:
- Possess a Bachelor's Degree in an applied science or engineering field.
- Have a minimum of 5 years of experience in Quality or Manufacturing, ideally in class II/III or equivalent environments.
- Hold at least 3 years of experience in Design Control, Product Development
- Exhibit proficiency with 21 CFR 820, ISO 13485, and ISO 14971.
- Showcase strong organizational skills.
- Demonstrate proficiency in using Microsoft Excel, Word, and Visio.
- Show experience in root cause analysis.
- Possess exceptional cross-functional communication skills and meticulous attention to detail.
- Demonstrate the ability to tackle technical challenges using creative problem-solving techniques.
