Quality Systems & Compliance Manager

Quality Systems & Compliance Manager

About the Role

We are seeking an experienced Quality Systems & Compliance Manager to lead our quality and regulatory compliance efforts. You will be responsible for ensuring that all manufacturing and product release activities meet applicable regulations and industry standards. This is a strategic position ideal for someone passionate about maintaining the highest quality and safety standards in medical device manufacturing.

In this role, you'll work collaboratively across functions to ensure regulatory compliance, maintain inspection readiness, and drive continuous improvement in our quality management systems.

What You'll Do

• Lead Compliance Initiatives – Oversee compliance activities throughout the device lifecycle, incorporating Risk Management principles and ensuring adherence to ISO 14971, ISO 13485, EU Medical Device Regulation 2017/745, and other applicable standards
• Manage Quality Assurance – Direct quality assurance and quality control activities across the product lifecycle, including validation strategies and protocol oversight
• Develop Training Programs – Define quality training requirements and coordinate programs for all personnel
• Oversee Audits & Inspections – Manage internal audits, supplier audits, and maintain inspection-ready status
• Lead Supplier Quality – Administer the supplier quality program, coordinate with vendors, and ensure specifications are consistently met
• Guide Product Documentation – Provide expertise to development teams on medical device documentation, design verification, and regulatory requirements
• Approve Labeling & Artwork – Ensure all labeling and artwork comply with international regulatory standards
• Manage Change Controls – Administer the Change Control System and ensure regulatory impact assessments and documentation are properly maintained

What We're Looking For

Experience & Education:

• Minimum 5 years of professional experience in pharmaceutical or medical device industries
• At least 3 years in a supervisory or leadership capacity
• Bachelor's degree in life sciences, engineering, or a related field

Technical Expertise:

• Strong knowledge of medical device regulations (21 CFR Part 820, EU MDR, ISO 13485:2016)
• Familiarity with quality management systems and regulatory documentation tools
• Proficiency with standard business software (Word, PowerPoint, Excel)

Personal Qualities:

• Excellent written and verbal communication skills
• Proven ability to manage multiple projects and meet strict deadlines
• Strong collaborative mindset with ability to work across all organizational levels
• Analytical problem-solving and sound decision-making capabilities
• Professional maturity and cultural awareness
• Ambition and readiness to take on increasing responsibility

Why Join Us

• Competitive salary range: $90,000–$115,000
• Performance bonus: 10% annually
• Comprehensive benefits package with 100% employer-paid premiums for medical, dental, and vision coverage
• 401(k) with 100% match on first 4% of contributions and 7% safe harbor plan
• Tuition reimbursement and professional development support
• Generous PTO and company-observed holidays
• On-site position offering stability and community