Job Summary:

The Quality Operations Inspection Engineer will provide mechanical inspection of all products, components and adhere to quality system policies. This individual will support new product launches and the manufacturing lines that produce our products. This role will include but is not limited to design review, design for inspection (DFI), writing and reviewing inspection plans, CMM and automated optical measuring system programming, and working on process validation (IQ, OQ, PQ) to determine and develop the best methodology for the inspection of parts.

Duties and Responsibilities:

• Will be responsible to serve as the lead and SME in the set-up, programming (if required) and usage of various inspection technologies.
• Will also be responsible to develop, train and perform precision inspection verifications on mechanical and plastic parts, components, assemblies and materials. Including but is not limited to first article parts, in-process and final inspection for workmanship and conformance to specifications / drawings.
• Will serve as a subject matter expert to recommend methodology for inspecting devices.
• Will utilize inspection equipment such as micrometers, gauge blocks, dial indicators, height gauges, optical comparators, vision systems (Keyence IM and VR) and CMM (Zeiss-Calypso) .
• Approves or rejects items and documents inspection results as required. Communicates with internal and external customers as required to resolve inspection issues.
• Read and interpret engineering drawings, work instructions, inspection plans, travelers and other records.
• Will be responsible for the review and approval of Prototype/Validation/Production inspection plans and quality document changes.
• Meet or exceed established quality targets.
• Support production improvement efforts.
• Maintain a safe, clean and orderly workplace.

Qualifications:

• B.S. in Engineering or related discipline with a combination of college coursework and experience.
• Minimum of five to seven years of hands-on quality inspection experience in a manufacturing environment.
• Experience with plastic injection molding and mechanical inspection
• Knowledge of GD&T principles.
• Experience using calipers, micrometers, pin gages, thread gages, and measuring microscopes.
• Experience with utilization and programming of automated optical inspection systems and CMM equipment.
• Excellent Technical Skills
• Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations 21 CFR Part 820, ISO 13485:2016, EU MDR, ISO 14971:2019.
• Demonstrated knowledge of ANSI/ASME Y14.5 GD&T principles including a solid understanding and use of feature controls.
• Experience working with new product launch teams.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency (MS Office – Word, Excel and Outlook) and ERP systems
• Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.).
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service.
• Experience leading and conducting audits.
• Certified Quality Engineer preferred.

Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts, and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations.

Pay: $75,000.00 - $113,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Parental leave
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person