The Quality Engineer can heavily influence the company's compliance with quality system regulations and standards for product inspection, engineering design controls, and design change controls.

Essential Duties and Responsibilities:

• Investigating and supporting individual customer product complaints as necessary and participating in summarizing and reporting summary results of complaint investigations and evaluations.
• Assuring that the Quality System is defined, documented, evaluated, improved, and followed by establishing minimum policy requirements and applicable controlled documents.
• Conduct Process Validations to include applicable required risk management activities as necessary to support Manufacturing and Quality.
• Oversight of nonconforming material to include reports, support of daily Material Review Board (MRB), and proper disposition of product.
• Support for New Product Development (NPD) teams about 21 CFR Part 820, Part 1271, and associated EU/Canadian standards. 
• Support for establishing, documenting, conducting, and maintaining the company document control system including change control and record keeping.
• Support Research & Development with reviewing and approving design inputs and outputs to support the development process.
• Oversight of applicable regulatory and manufacturing standard reviews to ensure the system maintains State of the Art compliance. 
• Documentation, release, and communication to stakeholders (including company personnel) of changes to company supplier quality assurance policies and procedures.

Qualifications:

• Two years experience in an FDA regulated environment using technical specifications and documentation desired. 
• Proficiency in Microsoft Windows and Office applications (e.g., Word, Excel, PowerPoint, Access) required.
• Must possess excellent reading, writing and verbal communication skills.
• Knowledge of regulatory medical device and international quality standards desired.
• Ability to interact with colleagues and suppliers in a professional manner.

Education/Experience:

• Bachelor preferred and/or combination of experience
• ASQ Certified Quality Engineer certification 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

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.

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.