Quality Manager

Full-time

Kalamazoo, MI

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 Ontario  (Woodbridge, Concord and Barrie) and Kalamazoo, Michigan. Sterling manufactures success. 

About the Role

The Quality Manager proactively leads the quality management areas with the tactical and strategic requirements to ensure quality , customer satisfaction and profitable company growth. The role reports to the Director, Global Quality.

 Key Responsibilities include:

• Lead and develop the site quality teams. Collaborate and support quality engineering  focused on analyzing, developing, and implementing quality standards and processes for new product launches for contract customers at the sites.
• Collaborate with the site leadership to ensure that site complies with internal and external requirements and regulations.
• Oversee quality at the site including, in process inspection and measurement, final process inspection and measurement, and quality record review.
• Formulate, document and maintain quality control standards and on-going site quality control objectives.
• Assists the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, non conformances, CAPA, FMEA, and process/equipment/software verification/validation.
• Host regular meetings to review CAPAs and integrate findings including maintaining QMS.
• Oversee documentation of current process parameters and instructions to eliminate unnecessary process variations.
• Monitor and analyze key performance metrics and report them to the site leadership team. Achieve quality assurance operational objectives by serving as the appointed management representative and developing and monitoring appropriate site specific quality metrics to meet company objectives. Follow-up on quality KPIs and ensure appropriate measures are taken and communicated to reach/exceed set KPIs.
• Add customer value by developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, and statistical analysis to reduce variation, built in quality, etc.
• Provide guidance and coaching on problem solving and the proper use of product quality tools.
• Ensures the right talent is in the right place to meet strategic and operational goals, specifically right structure, right talent, in the right place (positions).
• Leads and ensures performance management process is executed effectively at the site – goals established and aligned to connect strategy and goals to individual goals and plans and all are communicated and supported through the performance management process throughout the organization.
• Supports the recruitment and selection of best talent for the organization.
• Supports the development of talent for full effectiveness in their current roles and for succession planning for future key roles.

Position Requirements:

• Minimum 7 years experience in a quality management or similar role.
• Experience in a quality function leadership role within the medical device industry working under ISO 13485, FDA and Health Canada Quality System regulations.
• Experience with Class II/III medical devices preferred
• Bachelor’s degree or above in science or engineering.
• Quality assurance educational courses, programs or certificates. Quality management certification preferred.
• Lead Auditor training certification preferred.
• Ability to solve complex problems including identification of strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems.
• Ability to effectively influence others in a matrixed organization
• Ability to listen and communicate effectively using verbal and written communication methods, including presenting ideas to executive leadership.
• Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization
• Ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation.

Benefits

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.