Engineer II, QA (Raw Materials)

Location Type: Not Specified

 

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As an Engineer II, QA in the raw material quality team, your responsibilities include completing planned, unplanned and detailed activities established in a quality system to ensure that quality requirements for products, processes, systems, or equipment are met for the raw material supply chain. Those activities include the planning and development of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements. The raw materials we support include both Chemicals and Manufacturing Components such as Amino Acids, Salts, Sugars, Vitamins, Bottles, Bioprocessing Containers and Filters.

Responsibilities

• Designs quality assurance programs and systems for product and/or process development and testing to ensure raw material quality and compliance with regulatory requirements.
• Works directly with customers/suppliers on complex critical quality issues/complaints. Leads issue/complaint resolution.
• 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). Act as a subject matter expert when determining clarifications and compliance to written standards, providing additional information for the site to ensure consistent application of quality processes.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts
• Multi-tasks efficiently in a high-paced environment
• Lead multi-functional risk assessments
• Collaborate effectively with internal teams (Incoming Quality Control Lab, Manufacturing, Packaging Engineers, Procurement, etc) on quality related issues and to complete tasks and projects

Education

• Bachelor’s Degree in Science or Engineering

Experience

• Minimum of 1-3 years of relevant quality experience in Medical device or Pharmaceutical industry
• Working knowledge of 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 $60,000.00-$90,000.00.

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