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Job ID :
43281BR
Location :
US - New York - Grand Island
:
Job Description

Responsibilities:

• Supports the manufacturing process owners and other functional area managers as a Quality Management System subject matter expert

• Leads complex cross-functional quality investigations in a variety of subject matter area to determine root cause and corrective actions

• Develops improvements to the Quality Management System to enhance compliance with regulatory requirements

• Leads teams to investigate deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken

• Reviews and approves changes to procedures and processes to ensure compliance with required standards

• Contributes expert process knowledge for product and process design and validation teams

• Works directly with customers (internal ,external, suppliers) on complex critical to quality issues

• Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects

• Conducts complex statistical analysis to analyze trends, and supports site level KPI metrics (e.g. yield improvements, CAPA, complaint and scrap reduction)

Minimum Qualifications:

• Bachelor’s degree in Engineering or Science Discipline.

• Minimum 5 years’ experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products

• Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment

• Quality standards (e.g., 21 CFR Part 820, ISO 13485)

• Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)

• Computer Systems (e.g. TrackWise, AGILE, E1/SAP)

• Proficient in team building and leading product quality investigations

• Techn ical report documentation and authoring procedures

• Resolution of Customer Complaints and CAPA’s

Preferred Qualifications:

• Quality Engineering experience in regulated industry including medical device, pharmaceutical, automotive or aircraft

• ASQ Certified Quality Engineer

• Lean and/or Six Sigma Black Belt




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.
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