Quality Technician - Cleanpac

BioHorizons; Alabama; Hybrid; USD 25,000 - 39,000; Full time

Benefits offered by this job

Medical plan options

FSA/HSA

Dental insurance

Wellness plan

401k with 5% match

Generous PTO

Short/Long term disability

Life insurance

Casual dress code

Social events

Job summary

BioHorizons is seeking a Quality Technician to assist under the QA/RA Manager, ensuring cleanroom compliance and quality inspections throughout receiving, in-process, and shipping stages. The role includes creating inspection templates in MS Office and maintaining meticulous records.

Qualified candidates will have ISO13485 experience, be detail-oriented, and able to work independently in a cleanroom environment with required PPE.

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 including Excel.
• Must be able to work in a cleanroom environment utilizing required garments and PPE.

Responsibilities

• Assist and operate under the direction of the QA/RA Manager, or designee.
• Support proper cleanroom operations, including gowning before entry and maintaining a clean work environment.
• Perform quality inspections at receiving inspection, in-process inspections, and a final shipping review.
• Create inspection templates with Microsoft Office programs and store completed records in designated file folders.
• Communicate quality or compliance concerns with urgency.
• Assist with investigations and problem resolution.
• Review quality records such as cleanroom monitoring and cleaning forms for correctness and completeness.
• Perform visual and dimensional receiving inspections as necessary.

Skills

Detail oriented

Follow procedures

Independent worker

Microsoft Office Suite

Excel

Cleanroom environment

Education

High School Diploma

Tools

Microsoft Office

Job description

The cleanpac Quality Technician assists and operates under the direction of the QA/RA Manager, or designee. The Quality Technician 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. Other duties may develop over time based on business needs and availability.

Essential Duties and Responsibilities:

Safety, Quality, and Regulatory Compliance:

• Maintain a Safe work environment and adherence to regulated products in a regulated environment.
• Adhere to the Quality Management System and support all quality initiatives.
• Create inspection templates with Microsoft Office programs and store completed records in designated file folders.
• Perform visual and dimensional inspections across all stages of production.
• Commnicate quality or compliance concerns with urgency.
• Assist with investigations and problem resolution.

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.

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 3 years’ experience in a production or shop environment is preferred .
• Medical Device manufacturing preferred.
• Cleanroom manufacturing experience preferred.
• 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
• 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
• 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.