The Cleanpac Quality Specialist assists and operates under the direction of the QA/RA Manager, or designee. The Cleanpac Quality Specialist must support proper cleanroom operations, including gowning before entry and maintaining a clean work environment. Tasks may include quality inspections at receiving inspection, in-process inspections, and a final shipping review. Additional duties include maintaining calibration/PM documents within an electronic system. Other duties may develop over time based on business needs and availability. 

Essential Duties and Responsibilities:

• Safety, Quality, and Regulatory Compliance:
  • Maintain a safe, clean work environment per documented procedures. 
  • Adhere to the Quality Management System and support all quality initiatives.
  • Perform receiving inspections for components used in production. Inspection instruments may include calipers, microscopes, or scales.
  • Perform visual inspections for in-process components. 
  • Review paperwork for completeness before final shipping.
  • Communicate quality or compliance concerns with urgency.
  • Maintain calibration and preventative maintenance documents within an electronic gauge system and contact responsible parties for status updates as needed.
• Manufacturing:
  • Review quality records, such as cleanroom monitoring and cleaning forms for correctness and completeness. 
• Supply Chain and Material Handling
  • Perform visual and dimensional receiving inspections as necessary.
  • Other duties as assigned.

Qualifications:

• Experience with ISO13485 or similar quality systems.
• Must be detail oriented, able to follow directions and adhere to procedures in a structured work environment.
• Ability to complete tasks independently without constant supervision.
• Experience with Microsoft Office Suite required, including Excel.
• Must be able to work in a cleanroom environment utilizing required garments and PPE. 

Education:

• High School Diploma and/or combination of experience.
• Minimum 5 years’ experience in a production or shop environment is preferred. 
• Medical Device manufacturing preferred.
• Cleanroom manufacturing experience 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.