Thermo Fisher Scientific Job - 41342419 | CareerArc
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Company: Thermo Fisher Scientific
Location: Fremont, CA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Key Responsibilities:

  • Support and monitor new product development and product lifecycle project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations.
  • Participate and ensure proper design controls are appropriate during design reviews.
  • Manages the pre- and post-production Design Assurance/Quality Engineering activities as they relate to product lifecycle development.
  • Review and approval of validation protocols and reports.
  • Review test protocols and final reports for completeness and accuracy.
  • Ensure design changes are processed in accordance with current change-control requirements.
  • Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers' specifications/requirements for products.
  • Act as a liaison between key OEM partners for support and alignment; initiate change orders (DCOs, PCOs, MOCs, and PCNs) as appropriate.
  • Use risk management techniques in accordance with ISO 14971 for design and manufacturing and in vitro / medical device products.
  • Provide input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates.
  • Verify risk analysis records are properly addressed, accurate, and maintained.
  • Support supplier qualification, development and monitoring activities to ensure that products meet design and manufacturing requirements as part of Design Transfer and quality system sustainability (production, operations, supplier quality processes).
  • Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed.
  • Advise and evaluate product verification/validation activities.
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards, procedures and post-market surveillance when necessary.
  • Use Key Process Indicators (KPIs) or metrics to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
  • Participate in continuous improvement efforts, such as practical process improvement (PPI).
  • Support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.
  • Active participation and support of the internal audit process.
  • Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
  • Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.
  • Provide quality engineering support for investigations as required.
  • Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.
  • Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
  • Complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.

Required Qualifications:

  • Bachelor's degree with a minimum of 2 to 5 years of experience in medical device or in vitro diagnostics quality assurance.
  • Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company
  • Demonstrated and impactful experience in product and process validation, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC).
  • Ability to interpret trends and data, translating the information into actions, outcomes and improvements.
  • Excellent documentation skills, with a solid process orientation and effective attention to detail
  • Strong verbal and written communication skills
  • Self-starter and independent critical thinker, with the aptitude to work autonomously
  • Proficiency in all MS Office products.

Preferred Qualifications:

  • Quality engineering certification (ASQ CQE or CQA) desired
  • Knowledge of lean six sigma manufacturing processes
  • Additional professional training in lean processes such as green belt training a plus
  • Auditor Training (ISO 13485, ISO 9001)
  • Working knowledge of enterprise systems and tools (e.g., MasterControl, Agile, Oracle, QAD, SmartSheets)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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