Quality Assurance Engineer - Medical Devices (Cleanroom)

The Quality Assurance Engineer is part of a team responsible for ensuring Northgate Technologies’ sterile medical devices meet the highest standards for quality, accuracy, operating functionality, and reliability. This role will work directly on quality assurance to establish that the product meets the design requirements. This position will oversee quality for Northgate’s sterile, disposable products, including the design and manufacturing workflow. The Quality Assurance Engineer will work among a team of engineers, technicians, developers and project managers for direction, support and collaboration.

KEY DELIVERABLES

Establish Policies and Procedures

• Establish activities for the development, application and maintenance of quality standards for processes, materials, and products
• Develop standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical
• Develop sampling procedures, forms and instructions for recording, evaluating, and reporting quality and reliability data
• Develop methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility
• Collaborate with Regulatory Affairs to meet the requirements of the FDA and EU Medical Device Regulation
• Cleanroom environmental monitoring

Provide Insight

• Ensures management representation, when required, at audits of the quality system
• Engaged member of Corrective Action and Preventive Action (CAPA) investigations, and actions

Support Product Development and Manufacturing

• Expert resource on metrology for incoming, in-process and final quality inspection
• Organizes, writes and conducts training sessions on quality control activities
• Plans all required test fixtures and tools for the correctness of components and products
• Statistical analysis of cleanroom, and production activities to identify areas for improvement

QUALIFICATIONS, SKILLS AND WORKING CONDITIONS

Minimum Required Education and Experience

• Bachelor’s degree in Engineering
• Must have at least 2 years of work experience with regulated sterile medical products in an ISO Class 8 cleanroom environment
• 5 years’ experience in manufacturing/quality
• Ability to manage multiple, simultaneous projects and deadlines
• Ability to synthesize and document requirements
• Excellent written and verbal communication skills
• Must be able to work independently and in a team environment, including with cross-functional teams
• Working knowledge of Statistical software package (i.e., Minitab, InfinityQS)
• Knowledge of Microsoft Office
• Experience with Packaging Engineering

Preferred Skills or Knowledge

• Certified Quality Engineer
• Knowledge of CAD design software

Working Conditions

• Clean office environment
• Minimal travel, including international, as needed

At NTI, we are passionate about innovation and improving minimally invasive surgery. Since 1984, we’ve taken part in advancing laparoscopic surgical techniques by offering a growing portfolio of innovative, reliable and easy-to-use products and services. This passion has earned us recognition! NTI received the 2022 and 2023 Innovation of the Year Award from the Society of Laparoscopic & Robotic Surgery in addition to a 2023 Edison Award, which honors the best in innovation and innovators! And we haven't stopped in 2024! This year, we've won another Edison Award, a Big Innovation award AND we were named a 2024 Best Place to Work by the Big Intelligence Group! We know we can't do any of it without our talented employees! Our corporate culture revolves around our five core values: respect, trust, integrity, duty and innovation which we live and breathe every day! We are always grateful to have accomplished team members join us and help us strengthen our values. We offer competitive compensation, a strong benefits package, including paid time off and 401k with company match. NTI places high importance on the alignment of an individual’s experience with our business goals and initiatives. Join our company!