Design Quality / Assurance Manager

Design Quality/Assurance Manager

As an experienced Quality Manager, you will ensure that our products meet all regulatory and quality standards for a Class II and Class III medical device development and manufacturing company. This individual leads the quality team in design quality assurance (pre and post production) and executing inspection, testing, and release activities, while supporting continuous improvement and maintaining alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable standards

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 contract services.

Our vision is to be a leading contract design and manufacturing medical device company in the development and production, of permanent and temporary active and non-active implantable medical devices.

General Competencies:

• Knowledge of regulatory requirements including FDA regulations, ISO standards, and other applicable laws and guidelines.
• Understanding of medical device lifecycle to ensure compliance and maintain quality standards throughout the development and manufacturing process.
• Quality Control and Assurance, including inspections, testing, and validation methods to ensure that products meet predefined quality standards.
• Experience with design control requirements and design history files.
• Risk management to identify and mitigate potential risks in the development and manufacturing processes.
• Support internal and external quality auditing to ensure compliance.
• Continuous process improvement by identifying inefficiencies and implementing improvement initiatives.
• Strong leadership skills to motivate and guide the quality team and other departments to ensure quality compliance within the company.
• Effective communication with cross-functional teams, regulatory bodies, and both internal and external stakeholders.

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:

• Lead and develop the quality team personnel including: quality engineers, quality specialists, and quality control inspectors.
• Oversee the development and implementation of quality control procedures for manufacturing processes.
• Drive continuous improvement efforts to enhance the quality and efficiency of operations.
• Ensure timely and effective resolution of quality issues by driving investigations of nonconformances (NCRs), deviations, and out-of-tolerance (OOT) results; collaborate with cross-functional teams on root cause analysis and corrective and preventive actions (CAPA).
• Provide leadership, training, and development to team members to maintain a high-performing team
• Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
• Prepare and present quality reports to senior management and regulatory agencies as required.

Education and Experience:

• Bachelor’s or Master’s degree in engineering or a related field.
• Minimum of 5 years experience in quality management in the medical device industry.
• Minimum of 5 years experience managing a team.
• In-depth knowledge of medical device regulations, including FDA 21 CFR 820 and ISO 13485:2016.
• Experience with Class II/III medical device development and manufacturing is strongly preferred.
• Working knowledge of statistical process control, design control, and other quality tools.
• Excellent problem-solving and analytical skills.
• Strong communication and team collaboration skills
• Ability to work in a fast-pace 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.