Quality Engineer – O’Fallon, Missouri

About the company – At Synergetics™, we pride ourselves on our engineering creativity as we aggressively pursue opportunities to advance surgery in both ophthalmic and neurosurgical disciplines through clinically significant product development. This is made possible through our collaborative relationships with industry leading surgeons from around the world working to improve patient outcomes.

Essential Duties and Responsibilities

Corrective and Preventive Action

• Lead and participate in CAPA, customer complaint resolution activities, internal corrective actions, and continuous improvement activities using structured problem solving and project management tools.
• Lead Material Review Board for assigned value streams including resolution with supplier and internal personnel.

Process Development, Improvement, and Compliance

• Create, update, improve, and standardize inspection procedures.
• Initiate, review, and approve inspection forms, work instructions, Quality System Procedures, etc.
• Implement scrap reduction and reject reduction opportunities based upon data.
• Participate in 3rd party and regulatory audits as required.
• Identify and implement new technologies for product inspection and testing.
• Provide training to all levels of the organization.

Product Validation and General Process Support of Production

• Develop test methods for new products.
• Participate in design review process and product validations as departmental representative.

Validation and Verification

• Write protocols, perform and coordinate testing, and generate reports for new and changed product, processes, and equipment.
Supplier Development
• Perform audits on supply base as required.

OEM Customer Support

• Support new product launches.
• Integrate unique customer quality requirements into Synergetics Quality System.

Reporting/Other

• Develop reports for QA/RA, Operations, and Finance.
• Develop and deliver presentations for cross functional audiences.
• Perform special projects as required by business needs.

Skills and Specifications

• Knowledge of Quality principles.
• Capable of writing reports, procedures, and business correspondence.
• Ability to work individually and manage self driven projects.
• Demonstrated ability to solve problems, analyze system data, and implement appropriate solutions.
• Manage multiple projects while achieving deadlines.
• Attention to detail and accuracy in performance.

Education and Qualification

• Bachelor’s degree in Engineering or other field of science or equivalent experience
• ASQ Certification (CQA, CQE) preferred
• 2-5 years of professional experience minimum
• Medical device or pharmaceutical experience strongly preferred
• Sterilization / Microbiology experience is a plus

Contact

Please email resume to award@synergeticsusa.com