Fulltime
Kalamazoo, MI
Engineering @ Sterling
They say good engineers love solving puzzles. Every day, our team figures out how to build and improve our clients’ innovative MedTech solutions, manufacturing them at scale, ready to improve patients’ lives. It is a mission that requires multi-disciplined, creative, and flexible minds, working together for our clients’ success. Whether it is process, mechanical or quality control engineering, every member plays an important role, making our team stronger. If you want to put your engineering skills to work on delivering the next generation of medical devices to patients around the world, Sterling is the place for you.
We are seeking an eager Quality Engineering Specialist to join our growing team. The role is responsible for the launch and daily management of the processes, products, equipment, people, and customers in regard to the quality management system and regulatory requirements. The role reports to the Quality Manager.
Key Responsibilities include:
- Development and implementation of all quality related processes and documentation for new program development and current sustainment business.
- Direct involvement in manufacturing process development and continuous improvement as to meet or exceed the company’s quality metrics and process metrics for current and new business.
- Review, analysis, and resolution of customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions.
- Development and implementation of preventative actions and continuous improvements within the manufacturing and quality areas.
- Control of the non-conformance area (inventory, disposition, and associated costs)
- Purchase, management and review of gage equipment, certifications, and calibrations. Including programming CMM or other coordinate measurement equipment.
- Ensure the Gage calibration log is complete and up to date.
- Coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process, and use of quality metrics to ensure quality targets are met.
- Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
- Daily use of quality management system software and SPC systems.
- Participate in conducting supplier and internal system and process audits.
- Additional duties as requested by management.
Position Requirements:
- Engineering bachelor’s degree, with background in quality statistics, metrology, biomedical technologies preferred.
- 3-5 years’ experience in a quality department in a medical device OEM or contract manufacturer ISO registered environment
- ISO 13485:2016 Auditor Training Certificate preferred
- High volume workload requires conscientious attitude with accuracy and attention to detail.
- Knowledge and experience on:
- ISO 9001:2015 (ISO 13485:2016 preferred)
- Process capability and effect on processes, production, equipment, and assembly)
- Problem solving methods (5Y, Fishbone, 8D, etc.).
- Ability to be self-managed and directed from a satellite operation
- Medical device product development phases
- Medical device related ISO/IEC standards
- Six Sigma certifications a plus (green belt or higher)
- Proficient in with Microsoft office (outlook, excel, word, power point)
- Excellent communication skills (oral, written, technical)
- Excellent time management skills and the ability to be self-directed
- Customer focus and continuous improvement approach.
- Experience with machining, fabrication, and assembly operations a plus
- Must be able to work a flexible schedule and lift minimum 40 pounds.
- The position will require some travel (USA and Canada).
About Sterling Industries
Established in 1984, Sterling Industries provides end-to-end contract manufacturing and assembly of medical devices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs and fast-growing “scale-ups.” Registered with the U.S. FDA and Health Canada, Sterling helps clients deliver successful products through its vertical integration, managing the entire process, including the supply chain, manufacturing, assembly, testing, labelling, packaging and shipping. The company operates from facilities in the suburban Toronto (Concord and Woodbridge) and Kalamazoo, Michigan. Sterling manufactures success.
Company is in Kalamazoo, MI – position is onsite.
Profile J. Sterling Industries will consider and provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform Sterling of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation. All information collected will be protected under applicable privacy requirements.
We will review applications as they are received. Only qualified applicants will be contacted.
