VP of Quality

OSYPKA MEDTEC INC•Longmont, CO

21h•$225,000 - $275,000

About The Position

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.

Requirements

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
Lead medical device reporting (MDR)
Risk management expertise
Facility with design control and change control
Expertise in understanding and evaluating process validations
Strong communication and leadership skills
Continuous Improvement mindset
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.
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.
Excellent project management and organizational skills, with the ability to manage multiple projects simultaneously.
Thorough understanding of risk management principles and tools.
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.

Nice To Haves

Knowledge of statistical analysis tools and methodologies, such as DOE, SPC, and Six Sigma is preferred.

Responsibilities

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.