QA Engineer II

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our work in specialty diagnostics – from providing diagnostic assays and instruments to clinical monitoring across disease stages – improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.  

Protein Diagnostic Birmingham -Onsite

The Binding Site Group, a part of Thermo Fisher Scientific, is a global leader in specialty diagnostics, provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders.  The Binding Site’s Freelite® offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit www.bindingsite.com

Discover Impactful Work:

The Quality Assurance (QA) Engineer with demonstrated experience driving and sustaining improvement to products, while ensuring that those products manufactured meet internal, customer, and regulatory requirements. The ideal candidate will strengthen our quality system, promote alignment to Quality Assurance policies and requirements, and drive the execution of quality goals and objectives.

A day in the Life:

• Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and resolve next steps.
• Participate in change control activities for documents and manufacturing processes.
• Ensure accurate use of quality systems and processes.
• Provide mentorship and direction to ensure ISO/Quality system compliance.
• Model good practice for, completeness, and accuracy of Quality records.
• Lead problem requests (nonconformance's), complaint records, and corrective and preventive actions (CAPAs).
• Build, review, and revise quality policies and procedures, and perform training when needed.
• Review batch records for medical device products in accordance with cGMP, including good documentation practices (GDP).
• Ensure traceability to materials and equipment
• Identify and record any deviations related to a product's release; help process and review deviations as needed
• Supports internal and external audits, including audit of batch records and release activities for RUO products.
• Write, review and revise Standard Operating Procedures (SOPs).
• Identify and implement improvements using quality data, metrics and Practical Process Improvement (PPI) tools.

Keys to Success:

Education

• Bachelor’s degree in Science or Engineering, or related field is preferred. Equivalent education and experience can be substituted.

Experience

• 2+ years of relevant Quality/Manufacturing/Engineering or related experience in an ISO 9001, ISO 13485, FDA 21CFR 820 environment.
• The role is based supporting a team operating automated in-line filling and labelling equipment and therefore experience working in a similar environment is desirable.

Knowledge, Skills, Abilities

• Proven track record to collaborate in multi-functional teams.
• Demonstrated ability to conduct quality investigations including root cause analysis.
• Strong verbal and written communication skills in English.
• Knowledge of Quality standards (e.g. ISO 9001:2015).
• IVDR and ISO13485 knowledge / awareness preferred.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

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