QA and Regulatory Affairs Manager - 1
Saint Petersburg, FL 33716
Responsible for managing the Quality Assurance Department. May also manage Calibration Laboratory. Ensures compliance of the Company’s Quality Management Systems and products to ISO 9001 standards and to appropriate Hazardous Area and other regulatory requirements.
1) Ensures suppliers of products manufactured to Sensidyne specifications have the capability to manufacture and supply in accordance with Sensidyne requirements. Determines and maintains approved supplier list; conducts and coordinates supplier quality audits as required.
2) Coordinates and conducts internal product and quality system audits, quality improvement initiatives and manufacturing process audits to ensure compliance with Company quality standards and regulatory requirements.
3) Determines scope and coordinates calibration of company measuring and test equipment and fixtures using internal and external resources as appropriate.
4) Generates monthly yield analysis and other quality related metrics to monitor Company quality trends; takes an active role in helping to identify root causes and corrective actions and follows up to ensure continuous quality improvement.
5) Responsible for prototype and validation testing to support product development and assists in product design review and product improvement activities ensuring that products meet specified test criteria. May be involved in developing prototype test parameters and requirements, including software and firmware validation.
6) Develops, implements and maintains quality systems in accordance with required system and product standards and regulations.
7) Coordinates and provides guidance and assistance for outside assessment organizations (i.e., UL, FM, CSA) during periodic audits. Responds to and clears all audit non-conformances and observations in a timely and complete fashion.
8) Administers and coordinates new and existing product audit certifications with the appropriate organizations. This includes budgeting and forecasting expenditures, obtaining quotations, managing purchase order requirements and ensuring timely completion of projects by the assessment organization.
9) Ensures all product certification and design history files are maintained to current requirements.
10) Takes active role in ensuring the proper implementation of the Company’s Product Development Process. May serve as Project Manager or Lead as directed.
11) Develops and proposes the annual department expense and capital expenditures budgets. Controls expenditure levels within approved budgetary guidelines.
12) Manages Calibration Laboratory as directed.
13) Performs supervisory duties including prioritization of tasks, planning, goal setting, scheduling, face-to-face communication with subordinates, effective delegation and follow-up, performance monitoring with timely and appropriate feedback, and implementation of corrective measures as required.
14) Ensures all subordinates have accurate and complete job descriptions. Updates job descriptions as required.
15) Other duties as required.
Required Knowledge, Skills, and Abilities: (Submission Summary:
1. BS Degree in an Engineering or other technical discipline or equivalent technical experience required.
2. Minimum 10 years of experience in a manufacturing/quality assurance environment.
3. Minimum 3 years of experience in a supervisory or management role.
4. Strong management and leadership skills.
5. Excellent communication and administrative skills.
6. Good attention to detail.
7. Strong problem-solving skills
8. Statistical / analytical skills.
9. Excellent interpersonal skills.
10. Self-motivated and works with high sense of urgency.
11. Thorough knowledge of ISO 9001 Quality Management Systems requirements.
12. Knowledge of Hazardous Area Regulatory requirements.
13. Technical background in industrial instrumentation.
14. Computer literate in use of Word, Excel and Project applications.
15. Salary Expectation?
16. US Citizen or Green Card holder.
17. Complete Current Address?