Manager, Quality Systems

This position is primarily responsible for providing compliance oversight for local quality systems and procedures for the Fresenius Kabi medical device production unit in Warrendale, PA.

Responsibilities

• Develops and delivers quality compliance strategy in alignment with global quality, divisional, production unit, and local and international regulations and standards.
• Directly responsible for ongoing execution and improvements to the production unit’s quality system activities, including:
  • Corrective & Preventative Action
  • Management controls
  • Complaint investigations
  • Internal auditing
  • Change control
  • Document control
• Monitors the performance of local quality systems and reports to management periodically on compliance health, inspection readiness, and audit results.
• Develops and implements a cross-functional internal audit program to ensure that all worldwide regulatory and global quality system requirements are implemented and met at the production unit.
• Represents the local quality system during regulatory and external inspections.
• Prepares and manages local regulatory and external audits, including post-audit activities.
• Drives QMS initiatives throughout the organization.
• Partners with and leads functional quality management to develop and maintain high performing, scalable, and compliant quality systems.
• Interacts with other Quality Units within Fresenius Kabi Devices Division for resolution to compliance issues.
• Provides leadership and guidance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization.

Requirements

• Bachelor’s degree in a life science, engineering, physical science, or related discipline.
• 8–10 years of experience with in-depth knowledge of the regulatory environment for medical devices for globally distributed products, including:
  • 21 CFR Parts 11, 820
  • ISO 13485, ISO 14971
  • QSR, ISO, MDD, CMDR, MDSAP, and MEDDEV requirements
• Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
• Lead Auditor or ASQ professional certification highly desired (e.g., ISO 9001/13485 lead auditor, ASQ CQA).
• Experience dealing directly with FDA inspectors and other regulators during quality system audits.
• Clear, persuasive communication essential for explaining quality standards, presenting data, and influencing stakeholders at all levels.
• Must be able to effectively speak, read, write, and understand English to perform essential functions, including independently understanding policies, procedures, training materials, and workplace communications written in English.
• Proven ability to hire, develop, coach, manage, and motivate staff, including writing and administering performance appraisals.
• Proficient in computer software and applications, including intermediate/advanced functions of Microsoft Office (Word, Excel, PowerPoint, and Access) and/or PC SAS or other analytical software packages.

Applicants must be currently authorized to work in the United States for any employer and must maintain that authorization without requiring employer sponsorship.

Pay

• $115,000 to $130,000 yearly
• 10% annual target bonus

Benefits

• Medical, dental, and vision coverage
• Life insurance
• Disability coverage
• 401K with company contribution
• Wellness program