Quality Systems Engineer I

Quality Systems encompasses corrective and preventive action (CAPA) development, microbiology and sterilization sciences, auditing and support, and calibrations. The Quality Systems Engineer I will provide the highest possible level ofsupportforallinternal customer groups in a manner that fosters a culture of quality and continuous improvement within the organization.

This position is onsite in Utica, NY.

Role Responsibilities:

• Assist in the development and implementation of procedures usedtoassurethequalityofbothinternallyproducedproductandpurchased material.

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

• Support Quality Engineering, Manufacturing Engineering, 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, to include trending analysis. Drive improvements where needed.

• Maintain product bioburden and environmental sampling to include trending and analysis.

• Assist in the identification, investigation, and implementation of corrective and preventive actions (CAPA).

• Assist cross functional teams in therootcauseanalysis.

• Investigate and resolve process and product issues to reduce or eliminate quality problems 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 and ISO13485.

• Assist in the preparation and participate in domestic and international audits.

• Execute internal process audits and reporting, as needed, in an efficient manner such that Manufacturing processes and product are in full compliance with all regulatory requirements.

Required Qualifications:

• BS in Engineering or related discipline (microbiology, chemistry, biomedical engineering preferred)
• 0-3 years of related experience.

Disclosure as required by applicable law, the annual salary range for this position is $62,000 to $97,000. 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.

This position is not open to employer-visa sponsorship.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page 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

Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.