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Quality Assurance Systems Engineer

2 months ago

Utica, New York, United States CONMED Corporation Full time

The Quality Assurance Systems Engineer will deliver essential support and guidance in the Quality System domain to guarantee the integrity of processes and final products for both sourced materials and in-house manufactured items. This role involves overseeing corrective and preventive action (CAPA) initiatives, microbiological and sterilization practices, auditing, and calibration efforts to ensure optimal assistance for all internal stakeholders, fostering a culture of excellence and ongoing enhancement within the organization.

Key Responsibilities:

  • Act as a departmental liaison for various Quality Systems, developing expertise to provide guidance, feedback, and support across diverse projects and environments.
  • Contribute to the formulation and execution of protocols that ensure the quality of both in-house products and sourced materials.
  • Develop and/or assess testing methodologies, protocols, and documentation to validate the safety and effectiveness of products and processes.
  • Support Quality Engineering, Manufacturing Engineering, Manufacturing Operations, Safety, Regulatory, and Compliance teams regarding Microbiology and Sterilization Sciences.
  • Manage EtO, GAMMA, E-Beam dose settings, audits, annual evaluations, and validations, including the creation of protocols and final reports.
  • Oversee environmental monitoring within controlled areas, including trend analysis, and drive necessary improvements.
  • Maintain oversight of product bioburden and environmental sampling, ensuring thorough analysis and trending.
  • Assist in identifying, investigating, and implementing corrective and preventive actions (CAPA).
  • Collaborate with cross-functional teams in root cause analysis efforts.
  • Investigate and resolve issues related to processes and products to mitigate or eliminate quality concerns throughout product lifecycles.
  • Stay informed about relevant regulations, standards, and guidance documents, including QSR and ISO13485.
  • Assist in preparing for and participating in both domestic and international audits.
  • Conduct internal process audits and reporting efficiently to ensure compliance with all regulatory requirements.
  • Support management in departmental planning, including budgeting processes.
  • Develop and deliver training as necessary.

Required Qualifications:

  • Bachelor's degree in Engineering or a related field (microbiology, chemistry, biomedical engineering).

Preferred Qualifications:

  • Experience in the industry with practical knowledge of ISO13485, FDA 21CFR820, and other relevant regulations and standards.
  • Familiarity with QSR/ISO requirements, including 21CFR820, ISO13485, ISO14644, ISO11135, ISO11137.
  • Understanding of quality assurance principles and practices; quality certification (CQE, CQA, or Lead Assessor) is advantageous.
  • Knowledge of aseptic techniques in laboratory settings and sample collection.

Travel Expectations: 0-20%

This position does not qualify for employer-visa sponsorship.

Compensation: The annual salary range for this position is $62,000-$95,000, varying based on geographic location, work experience, education, and skill level.

Benefits:

CONMED offers a comprehensive benefits package tailored to meet diverse needs, including:

  • Competitive salary
  • Comprehensive healthcare options, including medical, dental, vision, and prescription coverage
  • Short and long-term disability, along with life insurance fully funded by CONMED
  • Retirement Savings Plan (401K) with dollar-for-dollar matching contributions, up to 7% per pay period
  • Employee Stock Purchase Plan with discounted stock purchase options
  • Tuition assistance for undergraduate and graduate courses

Diversity and Inclusion:

CONMED is an Equal Opportunity Employer and an Affirmative Action Employer, committed to 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 require reasonable accommodation under the ADA, please reach out for assistance.