Quality Systems

3 weeks ago

Kinston, United States IntePros Full time

he Quality Systems and Compliance Manager will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facility and Third-Party audits, across our multiple business units to ensure all meet intended level of quality for products and services. In addition, this role will trend client Customer audits to identify continuous improvement needs for client's system and processes.


Quality Systems and Compliance Manager Responsibilities:

  • Manage all audit related activities for client’s Audit program which includes supplier, corporate facility, and third-party audits.
  • Perform corporate facility audits of client’s sites to ensure compliance with procedures and applicable standards and regulatory requirements.
  • Perform audits of client’s suppliers to assess their Quality Management System, and ability to meet client’s quality standards, and applicable regulations. Provide Audit support for supplier selection process for new product development and procurement second sourcing strategies.
  • Develop and manage global strategies for standardized audit processes, audit tools, and audit plans and ensure use in all audit activities.
  • Manages and supports post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
  • Manage global audit schedule(s); Partner with key stakeholders to develop risk-based audit planning. Evaluate executed audits, including customer audits, to define current quality trends identified as risks/issues and determine impact on global quality systems and initiate actions, as needed.
  • Manage global relationship and activities of client’s third-party audit providers; Establish expectations and ensure Third Party audit providers perform as expected.
  • Establish and manage Auditor matrix which identifies trained auditors and areas of expertise; Enhance auditor training program to include specific trainings to expand auditor expertise and increase auditing capabilities. Establish processes and tools to increase visibility of audit and audit findings in a standardized format to client leadership.
  • Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations.
  • Collaborate with Supplier Quality Management to ensure alignment with supplier risk mitigation strategy and communicate on audit program priorities.
  • Generate, review, or approve Quality Assurance related documentation required for product.
  • Other duties as assigned.


Quality Systems and Compliance Manager Basic Qualifications:

  • Bachelor's Degree in Engineering or related technical discipline required
  • Master's Degree preferred


Quality Systems and Compliance Manager Work Experience:

  • Minimum 8 years (Mgr.) related experience required
  • Preferred Knowledge, Skills, and Abilities:
  • Experience in regulated industry such as pharmaceutical and medical device.
  • In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
  • Experience with SAP systems
  • Familiarity with document management databases, particularly MasterControl
  • Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze, and solve problems


Licenses and Certifications:

  • Certified Software Quality Engineer (ASQ CSQE) preferred
  • Six Sigma Green Belt Certification preferred

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