Job Type: Full Time
Location: Kalamazoo, MI
Reporting to the President, the Director of Quality and Regulatory is motivated, self-starter who leads and manages all Quality and Regulatory activities at Keystone to ensure manufactured products meet specifications and the operation maintains compliance with FDA and other governing body regulations and standards. The Director of Quality and Regulatory also promotes Keystone’s culture and values while providing leadership and direction to the Quality Department. In addition, the QA/RA Manage must maintain high-level internal and external relationships to help facilitate smooth and timely resolution of quality issues.
A successful Director of Quality and Regulatory must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively. This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.
- Lead, manage and hold the quality and regulatory team accountable.
- Provide positive, impactful input and participation in Leadership Team L10 meetings.
- Provide positive, impactful input and participation in Management Team L10 meetings.
- Implement and ensure that all KSG employees follow all Good Manufacturing Practices and SOP’s as defined by the Company policies, practices and procedures to ensure that Company quality standards, FDA and regulatory body standards and regulations are met.
- Develop and recommend plans, programs and policies required to meet established objectives.
- Ensure processes for manufactured goods and products meet current quality and regulatory standards established by the Company and FDA, and other regulatory bodies.
- Serve as designated Quality Systems Management Representative.
- Responsible for maintaining company ISO registration and compliance.
- Responsible for maintaining company FDA registration.
- Monitors upcoming changes in regulations and standards and advises how changes will impact the company.
- Act as the interface for the Company with the FDA during inspections and audits and for resolving and answering FDA comments.
- Address, investigate and resolve complaints and maintain required files and records and communicate with the FDA and regulatory bodies regarding potential problems with products in the field
- Responsible for internal audit program and ensuring audits are completed on time.
- Owns and leads management review meetings.
- Responsible for Medical Device Reporting (MDRs).
- Ensure that all records are reviewed and that current standards are met prior to product release.
- Owns supplier qualifications and ensures suppliers are capable of providing meeting required standards and regulations.
- Responsible for ensuring all personnel are trained according to the KSG QMS and are effective at their roles at all times.
- Routinely make decisions that immediately impact operations.
- Build and maintain relationships with all department managers, external partners and customers, and vendors to make decisions regarding operational activity and strategic goals.
Requirements and Qualifications
- Bachelor’s Degree in Engineering or Sciences, or equivalent work experience
- Minimum of 7 years’ experience in a regulated manufacturing environment.
- Experience and working knowledge of measurement equipment: calipers, rulers, micrometers, etc.
- Experience and working knowledge of current ISO 13485 standards, QSR, GD, GMP required.
- Understand and execute tasks per Standard Operating Procedures and Customer Specifications.
- Ability to operate hand tools, inspection equipment, and common office equipment.
- Ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings and weekends as necessary, to ensure minimal interruption to production.
- Excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
- Excellent documentation and organizational skills.
- Experience in new product development / processes.
- CQE or equivalent course work / experience desirable.
- Proficient in understanding of Med Device manufacturing processes.
- Experience with sterile barrier packaging is a plus.
- Experience working in a clean room is a plus.
- Experience with single use disposable medical devices is a plus.
- Experience with seal integrity and seal strength testing is a plus.
- References must be provided upon request.
- Basic computer skills (word processing, spreadsheets, database).
- Authorized to work in the US without sponsorship.
- Excellent full-time benefits including comprehensive medical coverage, dental and vision options as well as company paid life insurance and short and long-term disability insurance.
- Retirement savings plan with company match.
- Paid vacation and holidays.
- Flexible work environment, such as occasional work from home, is acceptable and encouraged as business needs and conditions allow.
- Professional development opportunities.
- Monday through Friday