Quality Specialist- Measurement Analysis, Improvement

Primary responsibilities include development and maintenance of the quality system, quality system reporting to management, and execution of the Company audit function.


Secondary responsibilities include management or support of vital quality assurance functions such as corrective action, management review, etc. Product specific quality engineering assignments as well as support for other quality assurance and regulatory functions may be included.

 

Duties & Responsibilities: (not limited to)

1. Interpret the letter and spirit of the Quality System Regulations for the manufacture of medical devices and integrate these requirements into the Company's operational systems. Assure that all quality systems are properly documented and comply with national and international regulations such as U.S. FDA's QSR, ISO 9001 and ISO 14385.

2. Maintain and execute vital system functions related to the evaluation, correction, maintenance and reporting of the quality system such as but not limited to internal audits, corrective action, management review, etc.

3. Perform quality audits of various company functions as needed including quality system audits, process/manufacturing audits, GLP and GCP audits. Develop audit plans and document reports. Develop and maintain the company's audit schedule. Assure follow up and correction of deficiencies.

4. Represent the company's quality function during third part audits including regulatory audits. If necessary, assist in the execution of other third party audits, such as OSHA.

5. Trend and report the status of the quality system. Prepare reports necessary for periodic management review as necessary.

6. Maintain the Company's Quality Manual.

7. Support regulatory affairs in the management of adverse events and customer complaint reporting including but not limited to process management, closure, tracking/trending, and reporting.

8. Communicate the requirements of the U.S. FDA QSR, 21 CSR Part 11 regulatory requirements, and any other predicate rule requirements to the organization to assist in the development of complaint processes.

 

Requirements:

 

Preferred:

 

1. Experience in Complaint Management, Corrective Action Management and Internal Audit Management.

2. Engineering or science degree

3. American Society for Quality certification as Certified Quality Auditor

 

Minimum:

 

1. 7-10 years of related quality system experience, preferably in medical device environment.

2. Experience in international quality system requirements as needed for CE marking.

3. Experience in a variety of quality disciplines necessary to evaluate, organize, and develop quality systems for operations, product development, regulatory affairs, quality control, etc.

4. Experienced in the use of various software applications including Visio or equivalent, ERP type software systems, etc.

5. Ability to work independently. Sound Judgment. Ability to work well with others. Ability to meet deadlines. Dependable and consistent work habits. Ability to organize meetings and teams and communicate project status effectively.

6. Bachelor's degree in a technical discipline.

7. Ability to lift 20 lbs.