Quality Systems Manager

4 weeks ago

Marlborough, Massachusetts, United States Quest Diagnostics Full time
Job Summary

We are seeking a highly skilled Quality Systems Manager to join our team at Quest Diagnostics. The successful candidate will be responsible for managing the quality management system and regulatory requirements to ensure compliance with all applicable regulations and standards.

The Quality Systems Manager will work closely with other department staff members to assist with CAPA assignments and ensure compliance of FDA, ISO, and various regulatory requirements. The ideal candidate will have a strong background in quality management systems and regulatory compliance, with excellent communication and problem-solving skills.

Key Responsibilities:

  • Manage the quality management system and regulatory requirements to ensure compliance with all applicable regulations and standards.
  • Work closely with other department staff members to assist with CAPA assignments and ensure compliance of FDA, ISO, and various regulatory requirements.
  • Train internal/external staff on quality management system requirements.
  • Prepare management representative meeting data/presentation and may be assigned management representative for assigned facility.
  • Follows corporate policies and procedures.
  • Manage complaint system (review, process, investigate and close complaints in timely manner, hold meetings, trend quality data, etc.) and post-market incident activities.
  • Manage post-market incident activities (field action, MDRs, EU/Canadian incident decision/reporting, field failure trending).
  • Assess risk related to complaint and post-market activities.
  • Sit on R&D project team meetings as the quality representative and assist/train R&D team in Design control documentation including risk management activities.
  • Trend Quality data. Monitor trends and create reports for management review.
  • Coordinate, manage and follow-up on quality projects.
  • Conduct/participate in quality audits (internal and external) and regulatory authority inspections to ensure risk to company is minimized.
  • Ensure appropriate design control documentation is developed and design history file is maintained.
  • Review change control documents and ascertain regulatory impact.
  • Perform other duties as assigned.

Requirements:

  • At least eight years successful employment in a clinical/pathology laboratory environment.
  • Experience in working effectively in an FDA-regulated environment.
  • Strong knowledge of quality management systems and regulatory compliance.
  • Excellent communication and problem-solving skills.
  • Ability to work in a matrix organization.
  • Flexibility to meet continuously changing priorities and challenges.

Work Environment:

Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review). Walking or standing within the office area to operate other office equipment (i.e. printer/fax) or within the laboratory. Required to wear PPE as appropriate when visiting testing locations. Must frequently respond to text/email communications and will be required to be aware of ergonomic principles. May be required to travel by airplane/train or drive long distances. Ability to follow verbal or written instructions and use effective verbal and written communication.

Education:

Bachelor's Degree (Required). Master's Degree.

License/Certifications:

ASCP Certification.

EEO:

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets

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