Quality 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. In this role you will be responsible for maintaining our quality management system and leading the Quality Team.
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:
· 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 Management Systems (QMS): ability to implement, refine, and maintain a robust QMS, including document control, risk management, change control, and other key quality processes.
· Quality Control and Assurance, including inspections, testing, and validation methods to ensure that products meet predefined quality standards.
· Risk management to identify and mitigate potential risks in the development and manufacturing processes.
· 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:
- Develop and oversee the implementation of the company’s quality management system in compliance with ISO 13485:2016, FDA regulations, and other applicable standards.
- Conduct internal audits to ensure compliance with quality and regulatory requirements and identify areas for improvement.
- Manage and maintain the company’s supplier quality program, including conducting audits and monitoring supplier performance.
- 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.
- Investigate and address quality issues and ensure timely and effective resolution.
- 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 QSR and ISO 13485:2016.
- Experience with Class III medical device development and manufacturing is strongly preferred.
- Experience with conducting internal and supplier audits.
- 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.
Compensation:
- $105,000 to $145,000 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: $105,000.00 - $145,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Ability to Relocate:
- Longmont, CO 80504: Relocate before starting work (Required)
Work Location: In person