Listing Info

Quality Assurance Technician III (IRC8756)

A Technician III is proficient performing inspections and testing at various stages of production of the product - from raw materials, sub-assemblies, and final assemblies to assure product quality and conformance to specifications and procedural requirements. QA Technician III analyzes problems, determines problem-solving techniques and exercises judgment in selecting appropriate solutions.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily

• Performs and documents all QA inspection and testing activities to assure conformance to specifications
  
• Audits various manufacturing processes to assure compliance and product segregation
  
• Monitors quality product in all stages of manufacturing and packaging process to determine proper sampling and variations in the process
  
• Assists QE by maintaining equipment calibration log and schedule/test calibration to ensure equipment is working properly and within calibrations
  
• Review donor records for compliance
  
• Compiles and reviews device history records to assure compliance and releases products to

Finished Goods

• Initiates non-conformance reports (NCRs) and follows-up to final disposition of nonconforming materials
  
• Assists in developing and implementing Corrective and Preventive Actions (CAPAs) using known problem-solving techniques
  
• Assists in developing and implementing Document Change Orders (DCOs)
  
• Redlines/revises specifications as needed, to assure QSR compliance
  
• Trains other QA Technicians on new or revised procedures
  
• Investigates and reports complaints on existing products as directed by QA Supervisor

Requirements

Quality Assurance Technician III (IRC8756)

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education:
  High School Diploma or GED

• Certifications: None

• Experience: 3-5 years related experience.
  
• Knowledge of GMPs (QSR) and/or ISO 9001 and ISO 13485 regulations.
  
• Experience with usage of common inspection tools (e.g., rulers, calipers): read blueprint drawings
  
• Knowledge of computer software programs including Microsoft Word, & Excel.
  
• Experience with usage of inspection techniques and knowledge of statistical sampling plans.
  
• Strong attention to detail
  
• Ability to balance and prioritize inspections and job responsibilities to support production
  
• Focused with a strong sense of urgency
  
• Good verbal and written communication skills, ability to communication and interact well with all levels of personnel
  
• Ability to work with a diverse group of people

• Gravimetric moisture analyzer
  
• Burst tester
  
• Calipers
  
• Micrometer
  
• Height gauge
  
• Timer
  
• Balance/Standard Mass
  
• Checkpoint monitoring system
  
• Pipettes
  
• Electric pallet jack
  
• Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment
  
• Strong computer skills are required.

Physical Requirements

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for computer purposes. The employee may be required to periodically lift and/or move up to 50 lbs. The employee will be required to work in a cleanroom environment wearing cleanroom attire (hood, face mask, and coveralls).

Adverse Working Conditions

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

Selection Guidelines

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

How To Apply

We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.

To find out more about our company, visit our website at: http://www.integralife.com/Careers/

No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V

Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity.All resumes submitted by search firms or agencies to Integra or its employees, agents, di