Sr. Quality Engineer

Role Summary

Senior Quality Engineer responsible for supporting the Design and Development group and Operations to ensure combination products, components, and materials in development comply with regulatory requirements and internal SOPs. Applies design control principles across the product life cycle from feasibility to commercialization, providing quality input to project decisions and deliverables.

Responsibilities

• This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
• Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
• Lead risk management activities and participate in cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
• Lead test method validation activities and Gage R&R studies for Combination Product
• Oversee calibration and preventive maintenance program
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
• Identify quality characteristics and validation criteria for components, subassemblies, and finished product
• Work with R&D in the creation of requirements for new products and engineering specifications
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
• Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
• Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
• Other duties/ activities may be necessary to support departmental or company goals

Qualifications

• A minimum of 8 years quality assurance/engineering in a regulated industry (medical device) is required
• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
• Experience with Risk Management process (Risk Management Plan/Report, FMEA's) and associated standards (ISO 14971:2019)
• Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation, etc.)
• Must be a self-starter and capable of working independently and within a team
• Experience performing statistical analysis (Six Sigma preferred)
• CQE, CQA preferred

Skills

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability
• Exceptional problem-solving skills

Education

• BS degree in Mechanical Engineering or related field is required
• Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485

Additional Requirements

• Understanding of regulatory requirements including FDA QSR, ISO 13485, EU MDR; Risk Management per ISO 14971