Job Posting – Quality Engineer – O’Fallon, Missouri

O’Fallon Missouri

About the company

Through continuous improvement and development of our people, our mission is to design, manufacture and market innovative surgical devices, capital equipment, accessories and disposables of the highest quality in order to assist and enable surgeons who perform surgery around the world to provide a better quality of life for their patients.

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

To perform this job successfully, an individual must be able to perform each essential duty.

Supplier Development and Management

• Develop/manage supplier development and qualification program.
• Perform audits on supply base and manage audit schedule.
• Develop supplier qualification requirements and coordinate approval of supplier into Synergetics system.
• Manage PPAP/First Article process for new/changed products.
• Manage supplier scorecard and other related supplier metrics.
• Interact routinely with Strategic Sourcing Manager, Engineering, Manufacturing, and Suppliers to proactively improve quality of components.

Corrective and Preventive Action

• Lead/participate in customer complaint resolution activities and internal corrective actions (root cause analysis, structured problem solving, corrective action reports, etc.) primarily related to supplier materials.
• Manage Supplier Corrective Action process for product quality and audit related issues.
• Participate in the Material Review Board.  Lead resolution activities with vendor and internal personnel.

Process Development, Improvement, and Compliance

• Identify/ implement new technologies for product inspection and testing.
• Create, update, improve, and standardize inspection procedures for incoming product.
• Develop/ manage “dock to stock” and reduced inspection program.
• Provide training to Quality Inspectors and Production Operators.
• Initiate, review, and approve inspection forms, work instructions, Quality System Procedures, etc.

Validation and Verification

• Develop test protocols, monitor/perform testing, and issue qualification test reports
• Participate in design review process as departmental representative.
• Write protocols, perform/coordinate testing, and generate reports for new/changed product and equipment.

Reporting / Other

• Develop reporting for Management Review, Operations, and Finance.
• Participate in 3^rd party and regulatory audits.
• Lead/participate in Kaizen events and other activities to support Lean initiative.
• Perform special projects as required by the Quality Engineering Manager or business need.

Skills and Specifications

• Strong knowledge of Quality principles, auditing practices, and supplier development
• Capable of writing reports, procedures, and business correspondence
• Ability to work individually and manage self-driven projects
• Ability to solve problems, analyze system data, and suggest appropriate solutions
• Work under stress to meet project deadlines
• Attention to detail and accuracy in performance

Education and Qualification

• Bachelor’s degree in Engineering, Biology, Chemistry, or other field of science, or equivalent experience
• 5 years experience in quality or operations minimum
• CQA or demonstrated audit experience required
• Medical device or pharmaceutical strongly preferred

Contact   Please email resume to award@synergeticsusa.com

Steve Puljak, Quality Engineering Manager

Synergetics, Inc.,

3845 Corporate Centre Drive,

O’Fallon, Missouri 63368, USA