Frederick, Maryland, USA
2 days ago
Engineer I, QA

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Environmental Conditions:

Both Office and Laboratory Setting (following Good Manufacturing Practices (GMP) Safety Standards)

Job Description:

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.

How will you make an impact?

The Quality Assurance Engineer I are responsible for supporting our manufacturing team by reviewing manufacturing documentation, inspecting product on the manufacturing floor, generating product certificates, and releasing product for sale. Additional responsibilities will include assisting with impact assessments, CAPA plans, risk assessments, and PPI events (Kaizens, value stream mapping, etc).

Shift Information

Monday-Friday 8a-4:30p

What the job entails

Review Device History Records (DHR’s) and associated documents to ensure that all documents meet our site GDP requirements and product quality specifications are met.Perform physical inspection of product to ensure compliance to packaging and labeling specifications.Identify non-conformances during product inspection and DHR review.Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations. Help resolve incomplete or unexplained issues found during the batch review with manufacturing.Assist manufacturing and other QA members with initiating problem notifications, completing impact assessments, and assisting with CAPA plans in TrackWise.Participate in multi-functional discussions for risk assessments.

How will you get here?

Education

Bachelor’s degree in Scientific/Technical field or equivalent work experience required.

Experience

1-2 years working experience in a regulated industry preferred.

Knowledge, Skills, Abilities:

Effective communication/interpersonal skills are required, both written and verbal.

Benefits

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, address complex and in-depth scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

Compensation and Benefits

The salary range estimated for this position based in Maryland is $53,300.00–$80,000.00.

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

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