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.
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.
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.
- Team lead for the organizational onsite requirements for the quality management system
- Development and implementation of all quality related processes and documentation for current and new business
- Direct involvement in manufacturing process development as to meet or exceed the companies quality metrics and process metrics for current and new business
- Monitoring the facilities overall performance and associated metrics and responsible for creating and implementing plans to achieve metric targets
- Development and implementation of preventative actions and continuous improvements within the manufacturing and quality areas
- 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.
- Work closely with Engineering Department and Operations Department to perform Validation activities (IQ/OQ/PQ)
- Perform FAI and PPAP
- Communicate and coordinate with management, administrative, operations, quality, and engineering departments
- Review, analysis, and resolution of customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions with operations
- Responsible for ISO and customer audits
- Daily use of quality management system software and SPC systems
- Responsible for document and record control
- Conducting supplier and internal audits
- Purchase, management and review of gage equipment, certifications and calibrations
- Control of the non-conformance area (inventory, disposition, and associated costs)
- Engineering bachelor’s degree or diploma, with technical and mathematical focus preferred.
- 5 years’ experience in a quality department in an ISO registered environment – medical device manufacturing preferred
- Medical Product validation experience is essential
- Knowledge and experience on:
- Process capability and effect on processes, production, equipment, and assembly)
- Problem solving methods (5Y, Fishbone, 8D, etc.).
- Ability to be self-managed
- Six Sigma certifications a plus (green belt or higher)
- Proficient in with Microsoft office (outlook, excel, word, power point)
- Experience with machining, fabrication, and assembly operations a plus
- Must be able to work a flexible schedule and lift minimum 40 pounds
- Must be able to travel between Canada and USA
Full-time employees are offered a comprehensive benefits package including:
- 401(k) with 1:1 match
- Dental Insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
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.