Quality Systems Specialist

Location
Kalamazoo, MI
Salary
Competitive
Posted
July 12 2017
Ref
51894BR
Position Type
Full Time
Job Description
Division Summary:When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
The Anatomical Pathology Division (APD) provides laboratories with the broadest portfolio of instrument and consumable solutions, from specimen collection and grossing to advanced staining and cover slipping. The Division generates $400MM in annual revenue and has 1,500 employees in 13 countries. The anatomical pathology product line includes Richard Allan Scientific, Erie Scientific, Microm, Shandon, and Lab Vision.
Position Summary: The Quality Systems Specialist coordinates the Quality Management System ensuring compliance to all relevant regulations and standards including ISO13485 and FDA QSR Part 820. This includes change management, record retention, training, and leading the internal audit program.
  • Establish and maintain procedures to control all documents and records.
  • Ensure compliance with record retention per corporate policy. Maintain offsite records storage and organization. Prepare records for destruction.
  • Drive continual improvement through all elements of the Quality Management System.
  • Internal Audits: Lead the internal audit program by developing and maintaining the internal audit schedule, coordinating training to ensure adequate internal auditors and lead auditors are available, ensuring adherence to schedule, and ensuring all findings receive proper follow up and closure.
  • Establish and maintain procedures to control labeling activities including label creation, change control, and linkages to associated documents.
  • Establish and maintain procedures for change control, including development and implementation of engineering change control process, label change control process, and process change control procedures. This includes the creation, development, implementation, training, and maintenance of an electronic change control system.
  • Support third party audits or investigations.
  • Ensure regulations and standards are available and up to date.
  • Maintain large volume of device master files.
  • Maintain internal / external audit schedule, conduct audits and track action item closure and effectiveness per ISO 13485.
  • Provide training to the organization in QSR, ISO 13485 and proper procedures as required.
  • Lead and participate on Practical Process Improvement teams.
  • Develop appropriate training when processes have been revised, maintain electronic training records.
  • Review and write/revise Quality Systems SOP's on a continuous basis to support continual improvement.
  • Lead cross functional teams to improve processes and associated procedures.
  • Maintain compliance with all company policies and procedures (safety, regulatory, etc.).
  • IQ/OQ and Service Report review for completion and filing.
Minimum Requirements/Qualifications:
  • Bachelor's degree
  • Quality Systems Regulations experience
  • Experience in a manufacturing environment
  • Proficient in MS applications (Excel, Word, Outlook)
  • Excellent communication and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
  • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
  • Creative, analytical problem solving skills
  • Ability to handle critical timelines in a multi-task environment
  • ISO 13485 Internal Auditor Certification preferred
  • Experience with Master Control as a Document Management tool is preferred
Non-Negotiable Hiring Criteria:
  • Bachelor's degree
  • Ability to handle critical timelines in a multi-task environment
  • Familiarity with Quality Systems Regulations and ISO13485
  • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

*IND-SDG



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.