Director of Quality

Team: Quality

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

WHY THIS ROLE MATTERS

The Director of Quality provides executive leadership for ProMed's quality and regulatory systems across medical device, pharmaceutical, and combination-product operations. This role protects patients, customers, and the business by ensuring quality and regulatory requirements are established, implemented, maintained, and continuously improved. As a member of senior staff and the Management Representative, the Director translates regulatory expectations into effective systems, develops the Quality organization, reports Quality Management System performance to senior leadership, and has the authority to halt production when product quality is suspect. The Director also supports ProMed's mission and values by reinforcing the company's brand, philosophy, systems, policies, and procedures in all aspects of the work.

WHAT YOU’LL ACHIEVE

• Maintain an effective, inspection-ready Quality Management System:

Establish, implement, and sustain quality and regulatory requirements in alignment with applicable ISO 13485, AS9100, FDA 21 CFR 820, 210 and 211 requirements, and related quality standards. Ensure QMS activities are deployed efficiently and effectively.

• Protect product quality and ensure appropriate product disposition:

Provide executive oversight for approval or rejection of components, in-process materials, packaging, labeling, drug product, production records, and product release. Ensure issues are investigated before release and halt production when product quality is suspect.

• Strengthen compliance and audit readiness:

Lead customer, FDA, and internal audit programs; oversee document control, cGMP/QSR/ISO 13485 training, supplier qualification, and controlled-document approval processes.

• Ensure validated, reliable processes and facilities:

Oversee equipment, process, and cleanroom validation activities and apply knowledge of analytical laboratory activities, validation, and data analysis to support sound quality decisions.

• Build a capable, accountable Quality organization:

Lead employees through clear expectations, performance reviews, goal setting, career planning, mentoring, and development.

• Provide visible executive quality leadership:

Serve as Management Representative, participate in senior staff and management review meetings, establish and track ProMed and Pharma quality objectives, and report QMS performance and risk to senior leadership.

• Advance continuous improvement and organizational effectiveness:

Identify and implement opportunities to improve the quality of work, employee effectiveness, and systems that support compliant execution.

Necessary Skills:

• Expert knowledge of FDA quality and cGMP requirements, including 21 CFR Parts 820, 210, and 211; ISO 13485; ISO 14971; ICH; USP requirements; and AS9100.

• Hands-on knowledge of pharmaceutical, medical device, and combination-product quality systems and regulatory compliance.

• Strong working knowledge of QMS, audits, supplier qualification, document control, validation, product release, investigations, and regulated training programs.

• Knowledge of analytical laboratory activities, validation practices, and data analysis.

• Ability to translate regulatory and technical requirements into practical, sustainable business processes and quality objectives.

• Executive-level leadership, coaching, mentoring, decision-making, and change leadership skills.

• Strong written and verbal communication skills with employees, customers, regulators, and senior leadership.

• Ability to manage multiple priorities and projects while maintaining sound judgment and appropriate escalation of quality risk.

• Technical understanding of medical device and pharmaceutical industry terminology and contracts.

• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Minimum Qualifications For The Role:

• Master's degree or advanced degree in business or business leadership.

• Bachelor's degree in chemistry, biochemistry, engineering, health care, biological sciences, or a related scientific discipline.

• Minimum 15 years of quality assurance and regulatory compliance experience in the development or manufacturing of pharmaceutical and/or combination products.

• Hands-on pharmaceutical, medical device, and combination-product cGMP experience.

• Demonstrated leadership experience in a regulated quality environment, including responsibility for quality systems and regulatory compliance.

Physical, Sensory, Cognitive & Neurological Demands:

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, stooping, squatting, kneeling, reaching, lifting, pushing, pulling, grasping, and repetitive movements throughout the workday.

• Requires frequent use of computers and standard office equipment and the ability to read handwritten and electronic information, adjust visual focus, hear, and communicate effectively.

• Requires the ability to move throughout office and manufacturing facilities, including tight spaces and even or uneven surfaces, while managing multiple demands.

• May require reaching at, below, or above shoulder height and pushing or pulling work-related equipment requiring approximately 25 pounds of force.

• Duties are primarily performed indoors in heated/air-conditioned, ventilated facilities and may include exposure to areas where chemicals are used for cleaning or equipment operation. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.