Quality Assurance Manager at HOFFER FLOW CONTROLS
Elizabeth City, NC 27909, USA -
Full Time


Start Date

Immediate

Expiry Date

23 Nov, 25

Salary

70000.0

Posted On

23 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Powerpoint, Communication Skills, Excel, Software

Industry

Pharmaceuticals

Description

Position Summary - The Quality Assurance Manager is responsible for establishing and maintaining the ISO-certified quality system under which the company operates. At present, the primary quality system utilized by the company is the current version of ISO 9001, ISO 17025. ATEX Directive 2014/34/EU and PED Directive 2014/68/EU. Additional specialized quality, design and manufacturing quality standards may be included as necessary.
Position Reports To: President
Subordinates: Quality Inspectors , Receiving Inspectors, Internal Quality System Auditors – Part Time

QUALIFICATIONS

  • Bachelor’s degree in business administration / related field or equivalent experience
  • Successful completion and certification of relevant quality system(s) management or Lean Manufacturing training. (Preferred)
  • Minimum 2 years of quality assurance experience in a management role.
  • Proficient in Microsoft Office software, particularly Word, Excel, and PowerPoint software
  • Ability to work individually or as part of a team.
  • Excellent written and verbal communication skills.
  • Self-motivated with high standards of integrity and work ethic.

3. Human Resources

  • Develop job description for all employees in the quality department.
  • Coach, train, and develop Quality Department staff member’s skills and capabilities.
  • Where appropriate, establish key performance indicator targets (KPI) and track their results.
  • Formally evaluate Quality Department staff member’s performance and capabilities utilizing the company’s employee performance evaluation system. Where needed, define and administer initiatives to improve their performance.
  • Openly communicate with the business unit’s employees to keep them apprised of the performance of the unit and the company.
  • Maintain an open, team-oriented work environment
Responsibilities
  1. Quality Management System
  • The Quality Assurance Manager is responsible for maintenance and integrity of the QMS system.
  • Work in conjunction with all department managers to create and maintain ISO 9001, ISO 17025, ATEX Directive 2014/34/EU and PED Directive 2014/68/EU compliant procedures, documents, and work instructions that form the company’s quality manual.
  • Record and investigate all corrective and preventive actions as defined by the ISO 9001, ISO 17025, ATEX Directive 2014/34/EU and PED Directive 2014/68/EU. Recommend and implement changes required to address each.
  • Call and conduct all quality system related meetings prescribed under ISO 9001, ISO 17025, ATEX Directive 2014/34/EU and PED Directive 2014/68/EU.
  • Train internal quality system auditors.
  • Conduct internal quality system audits as prescribed by ISO 9001, ISO 17025, ATEX Directive 2014/34/EU and PED Directive 2014/68/EU.
  • Coordinate with ISO 90001 and ISO 17025 and other quality system auditors contracted by the company to provide requisite third-party certifications.
  • Review and maintain CA/PA log, FAR log, Test Equipment log (TE-Log) and specialize training such as welder certification, forklift training etc.
  • Establish system for the regularly scheduled calibration of all calibration related tools and systems used. Establish and maintain records identifying all tools and systems and records of their calibration.
  • Establish systems to isolate and process (reject/rework/scrap) non-conforming raw materials and products.
  • Maintain materials traceability records as required by ISO 9001, ISO 17025, ATEX Directive 2014/34/EU and PED Directive 2014/68/EU.
  1. Sales and Production Support
  • Review and assist in quoting and completing special quality assurance requirements from customers.
  • Coordinate requests for independent quality audits and surveys from customers.
  • Maintain and report quality-related results and statistics to senior management and production management with any suggestions for improving results.
  • Coordinate with the management team to implement and sustain Continuous Improvement / Lean Manufacturing practices.
  1. Human Resources
  • Develop job description for all employees in the quality department.
  • Coach, train, and develop Quality Department staff member’s skills and capabilities.
  • Where appropriate, establish key performance indicator targets (KPI) and track their results.
  • Formally evaluate Quality Department staff member’s performance and capabilities utilizing the company’s employee performance evaluation system. Where needed, define and administer initiatives to improve their performance.
  • Openly communicate with the business unit’s employees to keep them apprised of the performance of the unit and the company.
  • Maintain an open, team-oriented work environment.
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