Quality Engineer Jobs

About The Position

Requirements

• B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 2 + years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience.
• 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.
• Must be capable to plan schedules and to manage multiple projects simultaneously.
• Excellent communication, problem solving, organizational, and interpersonal skills are required.
• Strong technical writing skills.
• Works independently with minimal direction or supervision.
• Decision intelligence.

Nice To Haves

• Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
• Design for Six Sigma training is desired along with knowledge of statistical methodologies.
• Involvement in back-room support process during external audits and/or inspections.
• Experience reviewing design verification and design validation protocols.

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.
• Review, assess, and approve product design documentation to ensure compliance throughout product development cycle.
• Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• A relentless focus on the safety and the efficacy of the medical device.
• Review and approve design verification and design validation protocols and reports.
• Ensure design activities prove design inputs and user needs are adequately addressed.
• Leads and provides support on risk management activities with a focus on clinician and patient safety.
• Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
• Support sustaining activities such as complaint investigation and complaint trending.
• Monitor and analyze manufacturing and service trends.
• Perform Predicate Device reviews and surveillance reports.
• 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.
• Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.
• Support internal and external audits.
• Provide support for audit preparation activities.
• Participate in the back-room as needed.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement 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
• Employee Referral Program incentives