Quality Assurance Manager

Quality Assurance Manager

Summary/Purpose

Under general guidance, the Quality Assurance Manager will develop, administer and maintain the quality management system and ensure compliance with product quality requirements and applicable regulatory requirements.

Essential Functions

1. Ensure that processes needed for the effectiveness of the Quality Management System (QMS) are established, implemented, maintained, and continuously improved.

2. Supervise and/or coordinate all positions related to the Quality Assurance Department such as Document Control, Quality Engineering, QA Inspection, QA Data Analysis, and other applicable quality assurance personnel.

3. Evaluate product concepts for compliance with product function and sterility as well as compliance with the appropriate governing regulatory requirements.

4. Monitor company quality functions for compliance with the Quality Systems.

5. Interface, as required, with State, Federal, and International Agencies.

6. Monitor and report to top management the performance of the quality system and any need for improvement.

7. Ensure the promotion of customer requirements throughout the organization.

8. Responsible for product quality issues.

9. Manage the supplier evaluation/re-evaluation/approval process. Plan and coordinate supplier quality surveys and audits.

10. Manage and continuously improve the quality assurance receiving and in-process inspections.

11. Manage and continuously improve the document control and document maintenance systems.

12. Manage and continuously improve the environmental monitoring system.

13. Manage and continuously improve nonconforming material processing.

14. Manage and continuously improve the Material Review Board process.

15. Manage and continuously improve the Corrective/Preventive Action system.

16. Manage and continuously improve the validation system.

17. Manage and continuously improve final product disposition.

18. Perform quality systems documentation review.

19. Plan or assist with the implementation of quality systems training.

20. Provide support in the internal audit program. Review and follow-up on quality audits (external & internal, supplier, customer, and regulatory).

21. Serve as the primary lead (host) for OEM customer audits. Provide support for regulatory and notified body/ISO Registrar audits.

22. Clarify, define, and defend the company’s quality policy.

23. Assist in the preparation of regulatory submissions.

24. Supervise employees making decisions regarding hiring, firing, discipline, and performance evaluations.

25. Communicate with coworkers at all levels.

26. Required to be present in the workplace during scheduled work hours.

27. Ability to work independently to perform daily operating tasks.

Marginal Functions

Participate in other work functions as directed.

Physical Demands

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• The employee is regularly required to sit, stand, walk, and use hands and fingers for keyboard, phone, and to handle or feel.

• The employee is frequently required to reach with hands or arms and talk and hear.

• The employee frequently will use either one or both hands to firmly grasp, push, and/or pull.

• The employee will occasionally reach overhead to grasp objects and lift or carry up to 40 lbs.

• It will be necessary to be around equipment and machinery and work in an office or warehouse environment.

• Normal 20/20 vision (with corrective lenses, if needed) required.

Qualifications and Requirements

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required.

Education

Bachelor's degree and two to four years related experience or equivalent combination of education and experience.

Skills

1. Ability to demonstrate leadership in job performance by example.

2. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations.

3. Knowledge of FDA QSRs.

4. Knowledge of current 21 CFR, ISO 13485, and ISO 14971 standards.

5. Knowledge of medical device manufacturing or related field.

6. Skill in assessing performance.

7. Ability to guide and delegate to subordinates.

8. Ability to analyze training needs.

9. Ability to administer employee discipline.

10. Manual dexterity required and ability to accurately perform detail-oriented work.

11. Ability to read, understand, and accurately complete documentation in English.

12. Ability to write reports, business correspondence, and procedure manuals.

13. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

14. Ability to be flexible in changing daily workload priorities as directed.

15. Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.

16. Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.

17. Ability to coordinate and synchronize multiple projects.

18. Must be able to present a professional attitude in auditing and other external contact situations.

19. Ability to effectively communicate in English with auditors, customers, suppliers, and other employees.

20. Ability to maintain composure when dealing with difficult customers.

21. Ability to understand and apply biocompatibility concepts and standards.

22. Ability to understand sterilization and packaging concepts and standards.

23. Ability to understand silicone physical properties.

24. Ability to understand silicone molding processes.

25. Ability to understand and apply risk management concepts and standards.

26. Ability to present departmental data clearly to an audience ranging from line personnel up to top management.

Mathematical Skills

Ability to apply advanced mathematical concepts such as exponents, logarithms, linear equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling, and factor analysis.

Computer Skills

Basic computer knowledge (Windows platform). Knowledge of Word, Excel, Access, and Outlook required.

Experience

5+ years of related experience administering key quality system elements preferred. Familiar with the use of analytical equipment. Advanced Excel knowledge. Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Training

Training requirements for this position are outlined in the Required Employee Training Matrix.