Unity Lab Service (part of Thermo Fisher Scientific) is looking for a highly motivated Quality Management Specialist with extensive experience to develop, support and sustain our Quality Management System for our North America Operations. The candidate must have exceptional drive, leadership and communication skills to harmonize our business to meet the compliance standards of ISO 9001 and the applicable elements of FDA’s 820 Quality System Regulation. The role will include expertise in a wide variety of quality functions along with providing regulatory guidance and expertise to our organizational team leaders to ensure our business and Quality Management System is proactive, effective and providing repeatable results.
- Support the business by continually improving the current Quality Management System for compliance to local, federal, and ISO regulations.
- Function as a strong Quality liaison to other functional departments, by providing meaningful quality support and ensuring productive cross-functional communication
- Collaborate and or support our functional leaders to develop effective quality procedures to meet compliance requirements and/or provide solutions to ensure a proactive quality model is in place
- Perform a variety of quality reviews and approvals related to the document management process, including facilitating organizational compliance to the training matrix program.
- Lead and perform internal audits as needed.
- Lead role to facilitate business integrations into the Quality Management System (inter-divisional or new acquisitions) for readiness state prior to target audit cycle.
- Lead, review and approve Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are thorough, complete and timely.
- Work with process owners to fully understand and provide guidance on appropriate investigation root cause, containment, corrective and preventative actions are thoroughly addressed to assure repeat deviations do not occur.
- Develop and report quality metrics as needed for score cards and quality review meetings.
- Provide functional support, oversight and enforcement of local and corporate record retention policies to ensure continued compliance.
- Develop, guide and facilitate the risk management processes within the quality team or with functional departments
- Participate in quality improvement projects and tasks as assigned by the Quality Manager.
- Review and approve customer quality survey forms and quality agreements to accurately reflect our quality scope and commitments
- Bachelor’s degree required, with 3-5 years applied experience of implementing ISO9001 and FDA’s QSR 820 requirements
- 3-5 years of auditor experience and report writing
- High degree of independence, self-motivated, self-drive and discipline to assure tasks are on completed on time.
- Applied experience in PPI tools and Lean techniques (investigations, Root Cause, Containment activities)
- An experienced team builder with ability to work collaboratively with various departments to identify and implement solutions to address quality/compliance issues
- Ability to work well in a matrix environment, the ability to multi-task, ability to solve practical problems and deal with a variety of changing situations.
- Experience in development and authoring of quality procedures, work instructions and forms.
- Experience leading and rolling out Projects and updates to the organization
- Use of Microsoft Word, Excel, PowerPoint, Outlook and Visio.
- Excellent written, communication and strong critical thinking skills
- Potential for 30% travel for related projects or audit support
- ASQ Certification or Equivalent
- 3-5 years of Lead Auditor experience w/certification
- 3-5 years’ applied experience in ISO 13485
- PPI or lean experience
- Experience with using MasterControl Quality Management Software
Location: focus areas: Madison, WI, West Palm Beach, FLA, Pittsburgh, PA, and Marietta, Ohio. Candidate can work remote in the Midwest or Eastern USA.
No direct reports.
This position is not approved for relocation assistance.
Join our Talent Community
If you're ready to make a difference in the world, you can do it here.Join