Find & Apply For Quality Control Systems Manager Jobs in Sturbridge, Massachusetts

Job Summary:

Optim LLC is seeking a self-motivated, detail-oriented and experienced Quality Assurance Manager to apply quality assurance processes throughout the organization and provide support to ensure that all quality and regulatory guidelines are being adhered to in working with our endoscope products.

Core Responsibilities:

Acts as the Quality Management Representative and PRRC for Optim while maintaining an effective Quality Management System.

Primary Duties:

Responsible for maintaining and improving Optim's quality management system in accordance with the

FDA, ISO

13485, and EU MDR. Implements and reports on quality policy and quality objectives. Leads all external audits performed at the facility such as FDA inspections, annual

ISO 13485

audits, ETL/CSA audits, government inspections, and customer audits. Creates internal and supplier audit schedules and manages the timely completion of each audit. Manages customer complaints and all corrective actions from investigation/root cause analysis to implementing action plans. Investigates all patient injuries and reporting requirements for each government agency. Oversees the Corrective/Preventative Action program inclusive of data analysis and fostering continuous improvement. Oversees all part/product inspection & testing, coordinates MRB meetings and disposition of non-conforming material. Oversees the calibration and preventive maintenance programs. Responsible for approval on all document change notices (DCNs). Responsible for running management review meetings. Participates in design and development activities. Provides support to the manufacturing floor when quality issues are identified. Works in a cross-functional capacity with all departments within Optim. Other Responsibilities Provides regulatory support for 501(k) submissions, CE technical files, international product registrations and MDR compliance.

Supervisory Responsibilities:

Oversees the Quality Department with a current staff of 2 employees.

Education and Experience:

BS in a technical discipline. Experience working in a medical device manufacturing environment.

ISO 13485, FDA 21CFR820

principles (3-5 years minimum).

Other Skills and Abilities:

Extensive attention to detail. Proven ability to organize and coordinate input from multiple departments. Good interpersonal skills. Demonstrated ability to identify problems and correct before they become significant.

Travel:

Some local travel may be required infrequently. Why join Optim LLC? Optim LLC develops, manufactures, and supports state-of-the-art endoscopy products and accessories that help medical professionals, law enforcement officers, and industrial users work more effectively and efficiently. We take pride in our work and accomplishments, which all begins with our employees. With an ever-growing market, we are looking to add and advance our workforce with meaningful career and growth opportunities. Our culture is centered around innovation, partnership, and empowerment.

Job Type:

Full-time Pay:

$95,000.00 - $105,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Vision insurance Application Question(s): Will you now or in the future require employment visa sponsorship (e.g., H-1B, O-1, etc.)? How long would your commute be? Does the pay range align with your expectations?

Work Location:

In person