Engineer III, QA
Thermo Fisher Scientific - Carlsbad, CA
posted 5 months ago
About the position
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, ensuring our food is safe, or helping find cures for cancer. We are looking for a self-motivated, experienced, and resourceful Quality Engineer with up-to-date knowledge and proven experience driving and sustaining improvements to the Quality Management System to ensure compliance with all applicable standards. This role is responsible for Quality Engineering support of Gels, NGS, and other products' manufacturing that are part of the Biosciences Division (BID) and Clinical Sciences Division (CSD), within our Life Sciences Solutions Group (LSG). LSG is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy, and Medical Devices. In this position, you will collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data, and determine next steps based on a risk-based approach. You will manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs), support change control activities for documents and manufacturing processes, assist with regulatory, customer, and internal audits, and provide guidance and direction to ensure ISO/Quality system compliance. You will also handle the maintenance, completeness, and accuracy of Quality records, perform training on Quality procedures/processes, create, review, and revise quality processes and procedures, and collect, analyze, trend, and report on quality metrics. Additionally, you will drive a culture of continuous improvement by employing Practical Process Improvement concepts and support complex, multi-functional quality issues in various subject matter areas, driving resolution and proactive solutions to customer complaints, backorder issues, and material disposition. Lastly, you will provide knowledge and guidance on validation and stability testing activities and perform other duties as assigned.
Responsibilities
- Collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data and determine next steps based on a risk-based approach.
- Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs).
- Support in change control activities for documents and manufacturing processes.
- Assist with regulatory, customer and internal audits.
- Provide guidance and direction to ensure ISO/Quality system compliance.
- Handle maintenance, completeness and accuracy of Quality records.
- Perform training on Quality procedures/processes.
- Create, review and revise quality processes and procedures.
- Collect, analyze, trend and report out on quality metrics.
- Drive a culture of continuous improvement by employing Practical Process Improvement concepts.
- Support complex, multi-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drive resolution and proactive solutions to customer complaints.
- Provide knowledge and guidance on validation and stability testing activities.
- Perform other duties, as assigned.
Requirements
- Bachelor's degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
- 3-5 years' or more experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
- Shown understanding of GMP guidance, including 21 CFR Part 11.
- Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
- Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Experience and knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001/13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
- Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis.
- Global Systems e.g. TrackWise, OCPLM, E1, LIMS.
- Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (OCPLM, Trackwise, LIMS, Master Control, ERP, etc.).
Nice-to-haves
- Experience with biological manufacturing processes.
- Project Management advanced experience.
- Certified Lean Professional or Six Sigma.
Benefits
- 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.
