Quality Systems Engineer I

ProvideQualitySystem support and leadershipin order to ensure thequalityof processes and finished devices for both purchased material andinternally produced product.

QualitySystemsencompasses corrective and preventive action (CAPA) development, microbiology and sterilization sciences, auditing and support, and calibrations to provide the highest possible level of support for allinternal customer groups,in a manner that fosters a culture ofqualityand continuousimprovement within the organization.

Duties and Responsibilities :

Function as departmental representative as needed for the variousQualitySystems. Develop subject matter expertisein thesystemsto provide leadership, feedback and supportin various projects and settings.

Assistin the development andimplementation of procedures used to assure thequalityof bothinternally produced product and purchased material.

Develop and / or review test methods, protocols and reports to verify the safety and efficacy of product and processes.

SupportQualityEngineering, ManufacturingEngineering, Manufacturing Operations, Safety, Regulatory and Compliance departments regarding Microbiology and Sterilization Sciences and requirements.

Coordinate EtO, GAMMA, E-Beam dose settings / audits / annual assessments and validations,including protocols and final reports.

Oversee environmental monitoring of the controlled areas, toinclude trending analysis. Driveimprovements where needed.

Maintain product bioburden and environmental sampling toinclude trending and analysis.

Assistin theidentification,investigation, andimplementation of corrective and preventive actions (CAPA).

Assist cross functional teamsin the root cause analysis.

Investigate and resolve process and productissues to reduce or eliminatequalityproblems on products, processes, and materials used throughout product lifecycles.

Remain knowledgeable and current with applicable regulations, standards, and guidance documents. Including, not limited to, the QSR andISO13485.

Assistin the preparation and participatein domestic andinternational audits.

Executeinternal process audits and reporting, as needed,in an efficient manner such that Manufacturing processes and product arein full compliance with all regulatory requirements.

Assist managementin department planning toinclude budgeting.

Develop and provide training as required.

Requirements :

BS in Engineering or related discipline (microbiology, chemistry, biomedical engineering) or equivalent experience.

Preferred Experience :

Industry experience having an applied knowledge of ISO13485, FDA 21CFR820, and / or other regulations and standards.

Working knowledge of QSR / ISO requirements. 21CFR820, ISO13485, ISO14644, ISO11135, ISO11137

Working knowledge of quality assurance principles and practices. Quality certification (CQE, CQA or Lead Assessor) desirable.

Working knowledge of aseptic technique in a laboratory setting and sample collection.

Travel Expectations 0-20%

This position is not eligible for employer-visa sponsorship.

Disclosure as required by applicable law, the annual salary range for this position is $60,000-$80,000. The actual compensation may vary based on geographic location, work experience, education and skill level.

The salary range is CONMED’s good faith belief at the time of this posting.

Benefits :

CONMED offers a wide array of benefits to fit your unique needs. Visit our for more information.

• 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

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