Senior Quality Assurance Engineer
2 days ago
Overview
At Thermo Fisher Scientific, you'll be part of a dynamic team that drives innovation and excellence in the field of quality assurance. Our company is dedicated to working with customers to find cures for cancer, protect the environment, ensure food safety, and deliver COVID-19 solutions.
Job Description
We're seeking an experienced Senior Quality Assurance Engineer to join our team as an Engineer III, QE. In this role, you will play a vital part in maintaining compliance and quality for our brand-new laboratory equipment. These innovative products impact education, research, and medical discoveries worldwide, improving lives every day.
Key Responsibilities
- Foster collaboration between customer, internal, and third-party audits.
- Author, review, and approve documentation such as SOPs, PFMEAs, and other critical documents.
- Investigate component issues, leveraging expertise in drawings, specifications, PPAP documentation, and quality fields to validate robust manufacturing processes.
- Monitor trending and evaluation of PNs or equivalent experience, deviations, and CAPA, ensuring their completion.
- Promote quality department process improvements and projects.
- Support validation efforts by assisting with validation documentation, performing qualification protocols, and compiling data.
- Review and approve procedures, training documents, and forms of moderate to high complexity.
- Lead and participate in CAPA investigations.
- Coordinate multi-functional teams supporting the Customer Complaint Process.
- Complete risk and impact assessments.
- Communicate directly with customers and internal groups.
- Drive product and process changes to enhance product quality.
Requirements
To succeed in this role, you should possess:
- Bachelor's degree in engineering or 5 years of direct Quality Engineering experience; OR Master's degree in Engineering field with 3 years of meaningful experience.
- Demonstrated ability with Quality Management Systems.
- 5 years of hands-on manufacturing experience leading investigation processes, including CAPA, NCM, complaints, and root cause investigations.
- Experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR 820, MDSAP).
Desirable Skills and Qualifications
- Strong understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820 requirements.
- Innovative thinking and problem-solving skills using Quality tools such as 8D, A3, 5-Why.
- Exceptional focus on detail and ability to identify and resolve compliance issues.
- Highly effective verbal and written communication skills.
- Self-motivated, proactive, and capable of rigorously adhering to deadlines.
- Ability to work well under pressure and multitask optimally.
- Understanding of manufacturing processes, product assembly, metal forming, inspection, and controls.
- Excellent interpersonal, organizational, and influencing skills.
- Skilled in using Microsoft software applications: Word, Excel, Visio, Teams.
- ASQ certification is desired.
Benefits
We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience, plus benefits package and opportunities for professional growth and development.
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