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Job Title: Quality Engineer III

Our client is looking for a self-motivated, experienced and resourceful Quality Engineer. This role is responsible for Quality Engineering support manufacturing that are part of Biosciences Division (BID), within of 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.

A Day in the Life:

• Collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data and determine next steps based on 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 review 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 drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and material disposition.

• Provide knowledge and guidance on validation and stability testing activities.

• Perform other duties, as assigned.

Education:

• Bachelor’s degree in Science required. Preferably in Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience:

• At least 3 years’ experience within a highly regulated field. Preferably in Medical Device or Pharmaceutical Industry supporting Regulated Products.

• Experience in GMP guidance, medical device, including 21 CFR Part 11 required.

• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.

Knowledge, Skills, Abilities:

• Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.

• Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.

• 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.

• 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. Root Cause Analysis, Risk Assessment.

• 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.).

Knowledge, Skills, Abilities (Preferred):

• Experience with biological manufacturing processes.

• Project Management advanced experience.

• Certified Lean Professional or Six Sigma.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.