Head of Quality Assurance

Osypka Medtec Inc.; Longmont (CO); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid Vacation

Paid Holidays

Insurance premium assistance

Job summary

Osypka Medtec Inc. is seeking a Vice President of Quality to lead QA/QC for class II/III medical devices, align with ISO and FDA requirements, and drive strategic quality initiatives.

This role oversees design control, risk management, and regulatory audits, mentors a growing team, partners with cross-functional groups, and reports to the executive team on quality metrics and risk.

Qualifications

• Bachelors degree in engineering or related field; advanced degree preferred.
• Minimum 10 years in quality assurance with 5+ years in the medical device industry.
• Proven leadership, communication, and cross-functional collaboration.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820.
• Experience with regulatory audits and EU MDR submissions.

Responsibilities

• Develop and execute quality strategies to ensure top product quality.
• Oversee QA/QC processes including design control and risk management.
• Ensure compliance with FDA, ISO, and international standards.
• Lead continuous improvement and CAPA across the organization.
• Mentor quality professionals and build relationships with stakeholders.
• Report quality metrics to Exec Leadership and Board.

Skills

ISO 13485

FDA regulations

Quality management

Design control

Change control

Process validation

Leadership

Communication

Education

Bachelors degree in engineering or related field

Advanced degree in quality management (preferred)

Tools

DOE

SPC

Six Sigma

Job description

The Vice President of Quality is responsible for overseeing all aspects of our company’s quality assurance and quality control processes. This includes developing and implementing quality strategies and ensuring the quality and compliance of our products and processes in accordance with ISO and FDA regulations within the development and manufacturing of Class II and Class III medical devices.

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.

• Thorough understanding of ISO and FDA regulations
• Expert-level knowledge in quality management and quality assurance techniques
• In-depth knowledge of requirements for Class II and Class III medical device development and manufacturing
• Facility with design control and change control
• Expertise in understanding and evaluating process validations
• Strong communication and leadership 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 execute quality strategies and plans to ensure the highest level of product quality.
• Oversee and manage all quality control and quality assurance processes, including design control, risk management, and documentation control.
• Monitor and maintain compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards.
• Collaborate with cross-functional teams to drive continuous improvement and implement corrective and preventive actions to address any quality issues.
• Lead and mentor a team of quality professionals to ensure a culture of quality and excellence is maintained throughout the company.
• Develop and maintain strong relationships with key stakeholders, including customers, suppliers, and regulatory agencies.
• Stay current on industry developments and best practices to continuously improve our quality processes and systems.
• Report regularly to the Executive Leadership and Board of Directors on quality metrics, trends, and any potential risks or issues.

Education and Experience

• Bachelor’s degree in engineering, science, or a related field; advanced degree in quality management or a related field, preferred.
• Minimum of 10 years of experience in quality assurance, with at least 5 years in the medical device industry.
• Strong leadership skills with the ability to develop, inspire, and motivate a team.
• Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders.
• Proven track record of successfully implementing and maintaining a quality management system.
• Experience with ISO 13485:2016 and FDA part 21 CFR 820 regulations is required.
• Experience conducting and participating in regulatory audits and onsite inspections.
• Must have working knowledge of requirements for submitting and meeting Medical Device Regulation for EU.
• Proficient in supporting all quality related actions for a 510(k) and PMA submission.
• Strong analytical and problem-solving skills with the ability to make data-driven decisions.
• Knowledge of statistical analysis tools and methodologies, such as DOE, SPC, and Six Sigma is preferred.
• Excellent project management and organizational skills, with the ability to manage multiple projects simultaneously.
• Thorough understanding of risk management principles and tools.

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

• Paid Vacation
• Paid Holidays
• Partial Payment by Company of Group Health, Dental, and Vision Insurance