- Date Job Description Completed: 28 December 2016
- Department Name: Quality and Regulatory Affairs
- Reports to: Director of Quality
- Supervises: None
- Exempt/Nonexempt: Exempt
Essential Duties and Responsibilities
- Acceptance Activities
- Develop and initiate standards and methods for inspection, testing, and evaluation of in process components and finished products. Perform necessary in-house testing; inspect in-process manufacturing processes and product, release finished goods shipments to customers.
- Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
- Coordinate, review, and approve validation of methods, equipment, products, processes, and systems.
- Implement quality methods throughout the organization; drive the use of quality tools in operations and product development, assist in resolving major quality issues.
- Plan and direct activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products.
- Devise sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Schedule and conduct Quality system audits of material and service suppliers.
- Develop and implement methods and procedures used in disposition of discrepant material, including failure investigations associated with Customer Experiences and material non-conformances detected during inspection, manufacturing, assembly, or service processes.
- Support workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
- Compile and write training material and conduct training sessions on Quality requirements and activities.
- Coordinate and oversee sterilization validation activities and partner with suppliers to document validation activities associated with material or services provided.
Responsibility and Authority Affecting Quality
- Initiate action to prevent the occurrence of any nonconformities relating to the product, process and Quality System.
- Identify and record any problems relating to the product, process and quality system.
- Conduct formal root cause analyses to identify appropriate solutions (corrective and preventive actions).
- Initiate, recommend or provide solutions through designated channels.
- Verify the implementation of solutions.
- Skills and abilities (required for the job)
- Excellent communication skills
- Excellent writing skills
- Strong organizational skills
- Detail oriented
- Ability to handle multiple tasks simultaneously
- A team player
- Education, experience and training (required for the job)
- Bachelor’s degree in Science or Engineering and three to five years experience in either the Medical Device or Pharmaceutical industry
- ASQ or related CQE certification
- Working environment
- Work Station Area: Office
- Special Factors in the Work Area: None
- The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
- The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
- The position requires the ability to communicate in person, telephonically and via email.
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