United Spinal Association Jobs

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 dosesettings/audits/annualassessments 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 causeanalysis.

• 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:

• BSinEngineering or related discipline (microbiology, chemistry, biomedicalengineering) or equivalent experience.

• Preferred Experience:

  • Industry experience having an applied knowledge ofISO13485, FDA 21CFR820, and/or other regulations andstandards.

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

  • Working knowledge ofqualityassurance principles and practices.Qualitycertification (CQE, CQA or Lead Assessor)desirable.

  • Working knowledge of aseptic techniquein a laboratory setting and sample collection.

Travel Expectations 0-20%

This positionis not eligible for 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.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.

Minimum Salary: 31200.00 Maximum Salary: 31200.00 Salary Unit: Yearly