Engineer I, QA

Work Schedule

First Shift (Days)

Environmental Conditions

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

Job Description

As an Engineer I, QA you will be responsible for maintaining the Quality Management System in a safe, quality and customer focused manner. You will be expected to finish planned and detailed activities implemented in a quality system to ensure that quality requirements for products, processes, systems, or equipment are met.

Responsibilities:

Works with subject matter experts on complex critical quality projects

Solves problems using analytical and creative thinking skills

Influences site quality goals & objectives based on in-depth knowledge of quality standards (i.e., ISO, GMP, etc).

Upholds departmental standards as required in a GMP environment

Drive a culture of continuous improvement by employing Practical Process Improvement concepts

Reports all non-compliance and support, engage in, and potentially lead teams assigned to making improvements

Multi-tasks efficiently in a high-paced environment

Assess and action team metrics

Lead multi-functional risk assessments

Collaborate effectively with internal teams to complete tasks and projects

Education:

Bachelor’s Degree in Science or Engineering (required)

Experience:

Minimum of 1-3 years of relevant quality experience in Medical device or Pharmaceutical industry

Quality standards (e.g., 21 CFR Part 820, MDSAP, ISO 13485 and FDA)

Experience with US Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia and British Pharmacopeia testing

Knowledge, Skills, Abilities:

Highly proficient with MS Excel

Strong interpersonal skills with the ability to actively listen, resolve conflicts, and effectively influence diverse collaborators, and team members.

Routine use of MS Teams and MS Word

Highly organized with attention to detail

Ability to be self-motivated, proactive, accountable, and flexible

Ability to work well under pressure, prioritize multiple tasks/projects, and meet deadlines

Strong problem-solving and analytical abilities

Effective written and oral communication skills

Proficient in use of Quality tools e.g. FMEA, Risk Analysis, CAPA

Compensation and Benefits

The salary range estimated for this position based in New York is $48,400.00–$72,550.00.

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

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.