Quality Systems Engineer I

As a Quality Systems Engineer I at CONMED, you will provide Quality System support and leadership in order to ensure the quality of processes and finished devices for both purchased material and internally produced product. This role encompasses corrective and preventive action (CAPA) development, microbiology and sterilization sciences, auditing and support, and calibrations. You will have the opportunity to provide the highest possible level of support for all internal 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:

• Function as departmental representative as needed for the various Quality Systems. Develop subject matter expertise in the systems to provide leadership, feedback and support in various projects and settings.
• Assist in the development and implementation of procedures used to assure the quality of both internally produced product and purchased 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 the root cause analysis.
• 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.
• Assist management in department planning to include budgeting.
• Develop and provide training as required.

Required Qualifications:

• BS in Engineering or related discipline (microbiology, chemistry, biomedical engineering preferred) or CONMED intern graduating with a Bachelors degree by June 2025
• 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 & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status. The Know Your Rights: Workplace Discrimination is Illegal Poster and Pay Transparency Nondiscrimination Provision reaffirm 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 ... option #5.

Minimum Salary: 32240.00Maximum Salary: 32240.00Salary Unit: Yearly