Quality Control Supervisor

Quality Control Supervisor

The Quality Control Supervisor is responsible for overseeing the Quality Control activities within the medical device manufacturing process for our Class II and Class III medical devices, ensuring that our products meet the required quality standards and regulatory requirements.

The role plays a critical part in maintaining an efficient and cost-effective production process while upholding quality standards required in the development and manufacturing of Class II and Class III medical devices.

Organizational Competencies & Cultural Values:
The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.

Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

General Competencies:

· Quality inspection and testing

· Team management and development

· Quality improvement within a manufacturing environment

· Proficiency with quality management systems, ISO Standards, and FDA regulations

· Organizational and problem-solving skills

· Communication and collaboration skills

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

Essential Job Functions:

• Develop and implement Quality Control procedures, policies, and guidelines in compliance with relevant regulatory standards (such as ISO 13485:2016, FDA, etc.).

• Manage and coordinate the activities of the Quality Control team to ensure timely and accurate completion of tasks.

• Train, mentor, and supervise Quality Control staff, providing guidance and feedback to improve their performance.

• Conduct regular audits of manufacturing processes and quality systems to identify areas for improvement and implement corrective action plans.

• Monitor and analyze production data to identify trends and implement preventive measures to maintain product quality.

• Investigate and resolve quality issues, customer complaints, and non-conformances in a timely and effective manner.

• Communicate with cross-functional teams to ensure quality objectives are understood and met through the organization.

• Collaborate with the research and development team to implement Quality Control procedures for new product design and development.

• Participate in supplier quality management activities, including supplier evaluation, audits, and performance monitoring.

• Ensure compliance with all relevant health and safety regulations and maintain a safe and clean working environment for employees.

Education and Experience:

• Bachelor’s degree in a relevant field such as biomedical engineering, quality management, or a related discipline.

• Minimum of 3 years of experience in Quality Control and quality personnel management, preferably in the medical device manufacturing industry.

• Strong knowledge of Quality Control principles, methodologies, and tools used in the medical device industry.

• Experience with ISO 13485:2016 and FDA regulations is required.

• Excellent leadership, communication, and problem-solving skills.

• Strong computer skills, including proficiency in using MS Office.

• Ability to work in a fast-paced and dynamic environment.

Physical Demands:

• Ability to sit or stand for long periods of time.

• Ability to lift, bend or move up to 25 pounds.

• Ability to adjust work schedule to meet deadlines and deliverables.

Compensation:

• $80,000 – 112,000 annually, depending upon experience
• Paid Vacation
• Paid Holidays
• Paid Sick Leave
• Partial Payment by Company of Group Health, Dental, and Vision Insurance
• 401(k) with limited company matching

Job Type: Full-time

Pay: $80,000.00 - $112,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to Relocate:

• Longmont, CO 80504: Relocate before starting work (Required)

Work Location: In person