Design Quality Engineer II

About the role

The Design Quality Engineer II supports all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. They serve as the quality engineering contact and a key member of the cross-functional development and sustaining teams. They take the lead with quality initiatives with inter-organizational impact following QSR, CONMED Policies, standards and regulations.

Responsibilities

• Supports and provides direction to product development teams for the required quality deliverables.
• Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements.
• Shows focus toward continuous improvement.
• Reviews, assesses, and approves product design documentation to ensure compliance throughout product development cycle.
• Reviews and approves engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• Troubleshoots and directs the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Able to perform data mining, analyze data and create trend reports.
• Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
• Investigates process and product issues identified through complaints and trend analysis of other conformance data.
• Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
• Directs and facilitates investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.

Requirements

• B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering or M.S. and 1+ years of medical device experience.
• Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
• Design for Six Sigma training is desired along with knowledge of statistical methodologies.
• Must be able to interpret and apply Quality Systems Regulations and ISO quality requirements and stay abreast of new industry standards and concepts.
• Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Experience reviewing design verification and design validation protocols.

Qualifications

• Must have 2+ years of medical device experience (or equivalent work experience).
• Preferred experience includes involvement in back-room support process during external audits and/or inspections.

Skills

• Interpret and apply Quality Systems Regulations and ISO quality requirements.
• Staying abreast of new industry standards and concepts.
• Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Experience reviewing design verification and design validation protocols.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retail Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses

Pay

$74,200 - $115,000 annually

Schedule

Full-time