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Thermo Fisher Scientific Manufacturing QC Leader 2nd Shift in Millersburg, Pennsylvania

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.

As a Manufacturing Quality Leader you'll help ensure quality product is delivered to our customers; safely and on time. You will partner with the production team to solve problems, improve processes and ensure that our quality management system (QMS) continues to mature with changing customer and regulatory expectations.

Responsibilities:

  • Assign QCTs to various Value Streams as required and according to production/inspection demand.

  • Problem Solving - customer complaints / atypical event management

  • Document Management - draft, edit review standard operating procedures (SOP's) and testing protocols

  • Testing - establish, optimize and execute test methods and test protocols

  • Continuous Improvement - utilize proactive process improvement (PPI) methodology to improve in the areas of quality, safety and efficiency

  • New Product and Process development - work closely with engineering to implement new products and processes

  • Auditing to site QMS, ISO 13485 and FDA 21 CFR 820 standards

Minimum Qualifications:

  • Problem Solving Experience

  • Knowledge of a QMS

  • Continuous Improvement experience, mindset, drive

  • Communication Skills

  • Interpersonal Skills - ability to work well with cross functional teams

  • Ability to gown, work in a cleanroom environment

  • Data collection, organization and presentation skills

  • Experience in document management

  • Creating, Revising Standard Operating Procedures and testing protocols

  • Strict adherence to safe working environments

  • Good Documentation Practices

  • Strong interpersonal, verbal and written communications skills are essential.

Preferred Qualifications:

  • Experience in Manufacturing Environment

  • Technical Writing Experience

  • Knowledge of ISO13485

  • Knowledge of FDA 21CFR820

  • Ability to read and understand CAD drawings

  • Understanding of Metrology

  • Experience with cGMP manufacturing

  • Lean Six Sigma Understanding

  • Bachelor's degree from an accredited higher learning program required, with majors in science or business related field.

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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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