Quality Systems Engineer
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. Quality Systems encompasses corrective and preventive action (CAPA) development, microbiology and sterilization sciences, auditing and support, and calibrations 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.
Duties and 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.
- BS in Engineering or related discipline (microbiology, chemistry, biomedical engineering) or equivalent 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.
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) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
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.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.