Job Description

Job Title: Quality Engineer II

Requisition ID: R-01182145

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 live 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.

What will you do?

• Support and monitor new product development and product lifecycle project needs in design controls for consistency with the internal quality management system and all ISO, FDA, and QSR regulations.
• Participate and ensure proper design controls are appropriate during design reviews.
• Leads 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 per 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.
• Provide feedback 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 material suppliers are controlled.
• 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 as needed.
• Use Key Process Indicators (KPIs) or metrics to demonstrate process effectiveness to identify areas for improvement, industry standard methodologies, and drive continuous quality improvement.
• Participate in continuous improvement efforts, such as practical process improvement (PPI).
• Support multi-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 needed.
• Provide quality engineering support for investigations as needed.
• Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.
• Work closely with production line and ensure controls are implemented and compliant with ISO 13485 and FDA QSR requirements.
• Complete work you're leading on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.

How will you get here?

Education

• Bachelor's degree in life sciences and/or engineering field

Experience

• 2+ years of experience in medical device or in vitro diagnostics quality assurance.
• Strong interpersonal skills with the ability to be a great teammate; 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 ability 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, 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 distributed team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

The salary range estimated for this position is $72,000 - $100,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Compensation and Benefits

The salary range estimated for this position based in California is $72,000.00–$100,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards