|NN, Inc. has an exciting opportunity for an experienced Quality Control Supervisor to join our team at our Hingham, MA facility! This position is an integral part of the Plant Engineering Team and reports directly to the Quality Manager. This is an exciting time of growth and change for the Power Solutions Group, and we are looking for a self-motivated team player who is driven by a passion to make a significant impact on our business operations and enhance value for our customers and stakeholders.
The Quality Control Supervisor’s basic function is to support manufacturing while making sure that our product’s requirements meet or exceed customer expectations. For this reason the Inspection Dept. reports to this position.
Through direct action and supervision of inspection, this position controls the efficiency of meeting documentation requirements. This position is directly responsible for facilitating smooth production recognized as a valuable agent in reducing non-productive work.
This position supports the management of documentation pertaining to but not limited to:
An equally important function of the Quality Control Supervisor is the ability to comprehend, communicate and support individuals as well as company financial objectives. Also, the Quality Control Supervisor is to assure, through monitoring and controls, necessary information is provided to management, on a timely basis, in order that it may render prudent financial decisions.
- Company policies and procedures, regulatory agencies as assigned, safety and environmental reporting and tracking. And for the ISO, AS9100, and NN Inc. Quality System.
- Medical device regulations, such as: FDA requirements, medical device files, complaint handling records, approvals and validations.
ESSENTIAL DUTIES AND KEY RESPONSIBILITY:
EDUCATION and/or EXPERIENCE:
- Manage daily operations of QA department in a machining/Manufacturing environment.
- Create Validation master plan and execute protocols to support products and process validation for equipment and processes utilized during design verification, validation and manufacturing
- Develop validation process and procedures to maintain compliance with FDA and customer requirements.
- Continuously improve existing quality procedure.
- Plan, develop and execute IQ/OQ/POs for equipment and process utilized during design verification, validation and manufacturing.
- Assist in the maintenance of ISO 13485-2016 systems, and AS9100D systems. Analyze and recommend appropriate changes to any procedures.
- Managing quality personnel, including training, evaluation and contribute to hiring and firing decision within the quality department.
- Oversees usage and maintenance of all quality control equipment and measuring devices. Ensuring all devices are properly utilized and are calibrated and maintained.
- Work in partnership with manufacturing to ensure proper training and inspection of parts at the machines and establishing proper protocols for in process inspections
- Working with customers to resolve all returns and product issues in a timely manner-including evaluation on credits, repairs or work charges.
- Oversight of corrective action system including determining root cause and implementing solution.
- Assist in development, implementation and maintenance of QA procedural manuals.
- Manages the inspection department in performing all test and checks while ensuring proper accepted sampling techniques are used and all paperwork is accurate and complete.
- Operation of SPC System.
- Development and maintenance of internal audit process.
- Prepares monthly reports and metrics on all quality areas including performance to goals.
- Maintains internal document control system
- Review and approve Customer Certification of Compliance documents
- Day to day oversight of quality operations and personnel, including movement of material through inspection operations.
- B.S in Business Management, Engineering or equivalent in experience is desirable.
- Five plus years’ experience with Medical device manufacturing Quality Control.
- Familiarity with manufacturing ERP system and MS office products.
- Advanced inspection capability & familiar with equipment function, and set-up.
- Must be able to recommend, prepare and evaluate company quality results
- Previous responsibility for simplifying documentation requirements and ability to provide efficient support to production.
- Management and organization of production requirements
- Cost of quality elements and improvements.
NN, Inc., a diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets globally. NN has 36 facilities in North America, Western Europe, Eastern Europe, South America and China.
NN, Inc. provides a comprehensive benefits package, including:
- Medical and dental insurance
- Employer-paid short-term disability and life insurance
- Voluntary vision insurance and other ancillary plans
- 401(k) plan with employer match
- Paid vacation and holidays