The Quality Auditor can heavily influence the company’s compliance with Quality System regulations and standards for quality audits and supplier compliance. The perception of suppliers and regulators about the level of competence of BioHorizons with respect to responsiveness to requests for information and the level of compliance with regulations.

Essential Duties and Responsibilities:

• Adhere with the company’s Quality Management System to ensure compliance with applicable regulatory requirements.
• Establishing, documenting, conducting, and maintaining the company internal audit program, including the scheduling of quality system audits to evaluate compliance with ISO 13485, 21 CFR Part 820, Part 803, Part 806, Part 807, and Part 1271 requirements, as well as related and similar requirements under the EU MDD/EU MDR and MDSAP regulatory compliance program over which the Quality Auditor has no direct control or responsibility.
• Ensuring that the Quality System is defined, documented, evaluated, improved, and followed by establishing minimum policy requirements and applicable controlled documents.
• Performing on-site audits according to the agenda, including audit closeout. 
• Preparing audit reports in a timely fashion as required per standard operating procedure(s).
• Issuing internal audit corrective action requests and following up on effectiveness. 
• Trending internal audit data and timeliness.
• Documentation, release, and communication to stakeholders of changes to the internal audit quality assurance policies and procedures (as necessary).
• Support the supplier quality audit program as directed.
• Participate in professional development and training opportunities to achieve necessary certifications and statuses.
• Implementation and maintenance of electronic quality management system software to facilitate the tracking of corrective actions issued during audits.
• Other duties as assigned.

Qualifications:

• Electronic quality management system software experience desired
• Outstanding verbal and written communication skills
• Outstanding planning and organizational skills
• Highly detail-oriented
• Ability to prioritize work and to perform multiple tasks simultaneously while adhering to deadlines 
• Microsoft Office Suite proficiency required

Education and Experience:

• Bachelor's Degree required and/or combination of experience
• Graduate degree preferred 
• Two years experience auditing in an FDA-regulated environment preferred.
• Experience in a regulated industry with Quality Assurance and/or Internal Audit program exposure preferred.
• Experience in an FDA-regulated environment using technical specifications and documentation preferred.

Benefits:

• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• Vision Benefits
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.