Senior Quality Engineer

Responsibilities:

• Risk Management SME: Lead cross-functional meetings to ensure Market Needs, Engineering Spec and risk are aligned and mitigated or properly justified for leadership approval and identify process risks for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).
• Provide feedback on new tests or test methods to resolve measurement discrepancies and ensure correlation in measurement method between in-process, Receiving Inspection and Risk Management in compliance with CPC requirements. For example, if a new test is required to mitigate a risk identified in Risk Management the NPI QE needs to be involved in the development and approval of that new test method.
• Attend team meetings and provides Quality Engineering input for potential design, process, and project risks.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Support Design/Service Transfer by providing input to design and manufacturing, Project Management and Supply Chain including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that new and refurbished tools and associated processes result in products that can be adequately manufactured and tested
• Review and develop design control documentation for accuracy, completeness and user-friendly content that meets the needs of target audience in support of device history records and device master records.
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ).
• Collaborate cross-functionally as NPI Quality Engineer; a Core Team Member, on new product/service development teams to ensure conformance with CPC QMS and lead deviation justification if necessary.
• Provides Statistical recommendations for formal DVT and Characterization testing as well as for process and other informal testing
• Collaborate with suppliers and applicable CPC functional teams in developing statistically valid, highly capable, repeatable, and reproducible test methods for formal DVT, Characterization and other informal testing.
• Develop validation plans and protocols to verify that components and supplier product meets requirements. Review and approve DVT test protocols. Provide data driven feedback on results.
• Review and approve process verification/validation test plans, protocols, reports, inspection procedures and associated documentation.
• Provide data driven feedback on results to resolve measurement discrepancies and ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.
• Ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.
• Problem Solving and Root Cause Analysis SME; Lead cross-functional meetings to investigate design-related issues (DVT failures), Facilitate, and conduct root cause analysis, Facilitate implementation and effectiveness of corrective and preventive actions (CAPA).
• Ensure traceability between design inputs, outputs, and test results.
• Performs other job duties as assigned to meet business needs.

Qualifications:

Basic Requirements:

• Bachelor's Degree in Engineering required.
• 7 years of experience in Quality, Manufacturing, or related field.
• Proficient with Quality System Regulations and ISO Quality System Standards.
• Strong understanding of ISO 13485 and ISO 9001.
• Excellent analytical decision making and problem-solving skills.
• Proven ability to resolve issues and participate in process improvement activities.
• Ability to define problems, collect data, establish facts and draw conclusions.
• Superb written communication skills, with a keen eye for detail and focused on target audience.
• Ability to effectively present information in one-on-one and small group situations.
• This role may require less than 10% of travel, domestically. Candidates should be comfortable with occasional travel as needed to support business objectives.