QA and Regulatory Affairs Manager at Sensidyne
Saint Petersburg, FL 33716, USA -
Full Time


Start Date

Immediate

Expiry Date

31 Oct, 25

Salary

0.0

Posted On

01 Aug, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Sensors, Excel, Administrative Skills, Regulatory Requirements, Transmitters, Data Driven Decision Making, Leadership Skills, Channel Partners, Interpersonal Skills

Industry

Pharmaceuticals

Description

JOB SUMMARY:

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. Ensures that best practices are in place for quality assurance of incoming materials and outgoing Sensidyne products.

SKILLS & KNOWLEDGE:

  • Strong management and leadership skills.
  • Excellent communication and administrative skills.
  • Good attention to detail.
  • Strong problem-solving skills.
  • Analytical mindset with experience in data-driven decision-making..
  • Excellent interpersonal skills.
  • Self-motivated and works with high sense of urgency.
  • Thorough knowledge of ISO 9001 Quality Management Systems requirements.
  • Knowledge of Hazardous Area Regulatory requirements.
  • Technical background in industrial instrumentation.
  • Computer literate in use of Word, Excel and Project applications.

EXPERIENCE AND EDUCATION:

  • BS Degree in an Engineering or other technical discipline or equivalent technical experience required.
  • Minimum 10 years of experience in a manufacturing/quality assurance environment.
  • Minimum 3 years of experience in a supervisory or management role.

Since 1983, Sensidyne has made precision industrial devices that keep workers safe and workplaces secure. A domestic and global leader in industrial Health & Safety, Sensidyne designs, manufactures, and distributes air sampling pumps & calibrators, and gas detection technology including transmitters, alarms, sensors, and detector tubes. Through our Channel Partners, we deliver to customers our best product innovations that ensure best practices for staying safe.

Responsibilities
  • 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, and communicates and tracks supplier corrective actions.
  • 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. Analyze quality metrics and drive continuous improvement initiatives.
  • Determines scope and coordinates calibration of company measuring and test equipment and fixtures using internal and external resources as appropriate.
  • 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 implementation of corrective actions and follows up to ensure continuous quality improvement.
  • 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.
  • Develops, implements and maintains quality systems in accordance with required system and product standards and regulations e.g. ISO9001. Ensures processes and procedures are in place and operating effectively to maintain an active ISO9001 certificate.
  • 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.
  • Administers and coordinates administration of 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.
  • Ensures all product certification and design history files are maintained to current requirements.
  • Takes active role in ensuring the proper implementation of the Company’s Product Development Process. May serve as Project Manager or Lead as directed.
  • Develops and proposes the annual department expense and capital expenditures budgets. Controls expenditure levels within approved budgetary guidelines.
  • Manages Calibration Laboratory as directed.
  • 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.
  • Fully engages in the Company’s Performance Appraisal process including goal setting, periodic reviews, and personnel development programs for direct reports.
  • Ensures all subordinates have accurate and complete job descriptions. Updates job descriptions as required. Provides HR with onboarding agendas for all new hires in the Quality Assurance department.
  • Oversees Quality Assurance systems and ensures alignment with company-wide goals and key initiatives.
  • Actively engage and collaborate cross-functionally with all departments to embed quality in every function across the Company.
  • Other duties as required.

Leadership

  • Approaches job and assignments with a well-developed sense of urgency and commitment and communicates this urgency to others.
  • Holds self personally responsible for meeting commitments and getting results.
  • Promotes a culture of high performance and professionalism in accordance with Company core values as reflected in the published culture document of the Company.
  • Proactively identifies, solves, and avoids problems. Encourages others to do the same without criticizing and threatening.
  • Strives for continuous improvement in all areas of responsibility.
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