Job Summary:

As the appointed Management Representative for regulatory agencies and standards including ISO, the Quality & Regulatory Control Manager has responsibility to ensure ongoing compliance with laws and regulations governing Garrison's products in all jurisdictions in which Garrison conducts business. This position leads engineering, operations, sales, marketing, and administration to plan and manage efforts supporting regulatory and compliance, new product launches, and post-market surveillance.  

Duties/Responsibilities:

• Leads company initiatives and provides compliance expertise to improve and maintain the QMS per FDA GMP requirements and ISO 13485.
• Collaborates with engineering, operations, and others on continuous improvement efforts, product verification, preservation, traceability, and other product/process regulatory requirements. 
• Reviews and evaluates customer complaints and product returns, identifying areas for improvement.
• Facilitates QMS and regulatory communication between functional departments and management.
• Maintains records of test results, defects identified, and other key metrics related to quality control.
• Analyzes quality control test results and offers feedback and interpretations of those results to management and/or staff. 
• Maintains current knowledge of trends, developments, and technological advances in device manufacturing and quality control in general.
• Drafts and maintains procedures, manuals, work instructions, and documentation for the manufacturing and QA processes.
• Monitors and periodically reports on production quality, nonconformance, trends, and underlying causes of defects in products or processes.
• Ceases production when serious product defects or risks arise. 
• Identifies training needs and conducts internal training and audits focusing on regulatory compliance to ensure all appropriate employees are knowledgeable of, and comply with applicable standards, policies, and procedures.
• Performs other related duties as assigned. 

Benefits:

• Bonus Pay
• Paid Time Off
• 401(k) with Profit Sharing Element
• Health Insurance - 3 Plans to Choose From
• Dental Insurance
• Health Savings Account Includes Annual Deposit from Garrison
• Flexible Spending Account
• Life Insurance
• Vision Insurance
• Short and Long-Term Disability Insurance
• Volunteerism Paid Time Off
• Employee Assistance Program
• Professional Development Program
• Referral Program
• Tuition Reimbursement
• No Cost Access to On-Site Fitness Room 
• Wellness Incentives including Gym Membership Reimbursements

Why Join Garrison?:

•  Family-owned / Family-values / Purpose-driven
  • We are a family-owned, debt-free, stable company in business for over 25 years.
  • We place high-focus on living our core values of teamwork, determination, quality, and continuous improvement.
  • We pursue a vision of innovating dentistry to restore healthy smiles worldwide.
  • Garrison plans to more than triple its revenues within the next 10 years.
• Highly-engineered medical products from complex manufacturing
  • We design and manufacture highly-engineered medical devices for dentists worldwide.
  • We place significant investments in innovation and technology.
  • Our products are protected by intellectual property and verified manufacturing processes that push the       limits of metal-forming and injection-molding.
• Market Leader
  • Garrison is a market leader for one of the most popular and reliable restorative dentistry procedures.
  • Our products are sold in 150 different countries.

Required Skills/Abilities:

• Excellent verbal and written communication skills, with ability to teach and train.
• Thorough understanding of quality control standards and methodology.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong coaching and leadership skills.
• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelor’s degree in related industrial, scientific, or business field preferred.
• Five years of Regulatory and Compliance Management.
• ISO 13485 Certification experience.
• At least three years of experience in a medical device manufacturing environment. 
• At least three years of experience applying ISO 13485 Quality Management Practices.
• At least three years of experience working with ISO, FDA, CE and foreign governments.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer. 
• Must be able to communicate information and ideas so that others will understand and must be able to exchange accurate information in these situations. 
• Must be able to lift up to 15 pounds at times. 
• Must be able to see details of objects that are less than a few feet away. 
• Must be able to recognize differences between colors, shades, and brightness. 
• Must be able to use fingers to grasp, move, or assemble very small objects.
• Must be able to hold the arm and hand in one position or hold the hand steady while moving the arm.