Director of Quality Assurance and Regulatory Affairs

For over 160 years, Haag-Streit has been a leading provider of medical equipment for ophthalmologists, optometrists, and opticians. Our experience is the foundation for developing, designing, and producing unparalleled medical instruments and equipment. From slit lamps to surgical microscopes, digital imaging to procedure chairs, we set the standard for precision mechanics and innovative technology.   Haag-Streit USA, headquartered in Mason, Ohio is the USA manufacturing, distribution, sales, engineering and service operating facility for the Haag Streit and Reliance Medical lines of products.
 

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The advantages of working at Haag Streit USA:

• Global Leader - Haag-Streit has been a leading provider of medical equipment for ophthalmologists, optometrists, and opticians for over 160 years.
• Strong sense of purpose – Our employees take pride in producing products that serve medical markets worldwide.  Our high-quality exam and procedure chairs, surgical stools, instrument delivery systems, treatment cabinets set the standard for reliability and precision.
• Stability and innovation - Established over 160 years ago, Haag Streit and Reliance Medical Products experience is the foundation for developing, designing, and producing unparalleled medical instruments and equipment.

What will you get in return?

• Excellent benefits package that starts on the first day of the month after you are hired 
  • Employee high deductible medical plan free to employees, no monthly premium
  • Employee vision coverage free to employees, no monthly premium
  • Additional plans and coverage tiers available at highly competitive rates
  • Basic life insurance and Short-Term disability provided at no cost to employees
  • Additional benefits including Dental, Critical Illness, Long Term Disability
• PTO, Vacation, 12 Paid Company Holidays

SUMMARY:

The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.

This role encompasses a wide range of responsibilities, including the development and implementation of quality system procedures, training associates on updated procedures, overseeing the Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and inspection teams in addressing quality-related challenges.

The director demonstrates excellence in cross-functional collaboration and effectively collaborates with teams at all organizational levels. Together, we are committed to upholding the highest standards of product quality and regulatory compliance.

ESSENTIAL FUNCTIONS: 

• General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws and standards.
• Responsible for the management of the Regulatory Affairs Processes, Registration, Non-Conformities, Product Recalls and Medical Device Reporting (EUMDR). Act as Person Responsible for Regulatory Compliance (PRRC).
• Maintain an effective quality management system (QMS) to ensure the consistent delivery of high-quality products. 
• Define and monitor key quality performance metrics, ensuring continuous improvement in product quality.
• In charge of HIPAA-related activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructions
• Overseeing Vigilance and Post-Market Surveillance activities
• Leads and guides the quality and regulatory team, offering coaching to the purchasing staff and fostering collaboration between inspection personnel and other departments.
• Manages staff selection, performance, development, and training to ensure team competencies align with business goals. 
• Identifies department training needs and develops materials to support company objectives.
• Responsible for the quality interests and concerns of projects – assisting design controls (Design Inputs/Outputs, Design Verification and Validation, Design and Process Risk Management – DFMEA/PFMEA, Design Master Record, Design History Files, etc.) 
• Expertise in validation, verification, and usability processes for new and improved products.
• Responsible for the System Computer Software Validation in compliance of the standards and regulations.
• Establishes and maintains Haag-Streit USA, Inc. System Procedures for regulatory compliance.
• Manages incident reporting and adverse event recalls.
• Responsible for Establishment Registration & Device Listing of class I and II Medical Devices
• Oversees Risk Management for Medical Devices according to ISO 14971
• Promotes the development of Quality Competencies and Quality Awareness throughout the organization.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Bachelor's degree in a relevant field or Engineering; advanced degree preferred with greater than 10 years experience in the creation and Management of Quality Systems.
• 3+ years of related experience in Medical Device FDA regulated industry to include product/process validation and solving technical problems. 
• Experience working as a Quality Engineer or Manager in a manufacturing environment Competent in FDA QSR, ISO 13485, and ISO9001, ISO14971, & EUMDR requirements.
• Strong knowledge of FDA regulations and international regulatory requirements.
• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.
• Demonstrated ability to work collaboratively across departments.
• Skilled auditor with knowledge of FDA, ISO13485, and EUMDR requirements.  
• Ability to read and interpret drawings and design specifications.
• Proficient in technical writing skills and communications.

Haag Streit USA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, genetic information, disability or protected veteran status.

If you are unable to apply online due to a disability, contact recruiting at hr@haag-streit-usa.com