Quality Assurance Engineer II
About the Job
QA Engineer II (Quality Assurance)
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.
Location/Division Specific Information
US – California - Pleasanton
How will you make an impact?
The role of the Quality Engineer is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Quality Engineer will work with various team members and internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments.
What will you do?
As a QA Engineer, you will help to ensure the Pleasanton site meets all the requirements for ISO 9001 and 13485. You will partner with various Operations teams to ensure robust procedures and processes are in place through change control and validation activities.
You will also help drive continuous improvement through the CAPA system; includes ensuring quality problems are addressed and appropriate measures put in place to prevent recurrence of issue.
Additionally, you will also help support product releases, writing/revising quality procedures, and providing mentoring/training to team members and the site.
- Review and approve CAPA in timely manner to ensure resolution of quality problems.
- Batch Record Review and Product Release, as well as periodic audits of records.
- Write, review and revise Standard Operating Procedures (SOPs)
- Provide input to and review of Validations for equipment, processes and software.
- Drive continuous improvement of processes and procedures using quality data and metrics.
- Perform other duties to support the Quality department as assigned.
How will you get here?
Bachelor’s degree (preferred) in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences
- Detailed knowledge of ISO 13485, 14971, GMP/GLP and GAMP5 (a plus)
- 3 - 5 years of work experience in Quality Assurance/Quality Systems role. Laboratory experience a plus (e.g. manufacturing, QC or R&D).
- Strong computer skills (Office, Project, Teams, Visio, Word, Excel) and experience in SAP, Agile, TrackWise, and Power BI. Advanced computer skill preferred.
- Experienced with Quality tools and methodologies including investigation/root cause analysis
- Experience with writing or reviewing validation protocols/reports for equipment, processes and software
- Experienced working & collaborating effectively with internal and external customers
Knowledge, Skills, Abilities
- Must be self-motivated, proactive, organized, and detail oriented
- Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet regulatory and business requirements
- Solid organizational and time management skills to meet deadlines
- Ability to balance complex and routine work activities, as well as competing priorities
- Highly energetic, positive attitude, and works well under stress
- Excellent communication and interpersonal skills with the ability to interact with all levels of the organization both orally and in writing; strong track record of working cross functionally;
- Ability to work in teams and independently to obtain results as required; including ability to resolve quality related issues in a timely and effective manner;
- Collaborate and communicate both vertically and horizontally in a way that commands both personal respect and mission acceptance
- Ability to manage escalations through to resolution
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.