Posted in Engineering 30+ days ago.
Location: Utica, New York
At CONMED, we do things the right way. Our Quality Engineering team comprises passionate engineers and specialists who maintain programs and systems that ensure adherence to quality standards and expectations. This team's work is crucial in ensuring that our products are accessible to our health care customers around the world.
We are seeking a self-driven and continuous improvement-focused Quality Engineer I to join our Utica, NY based Quality Engineering team. In this role, you will work cross-functionally to support production lines for a variety of medical devices. You will execute projects aligned with CONMED's Quality System, ISO 13485 standards, risk management, test methods, calibration and product line support. Your efforts in problem solving, innovation and cross-functional collaboration will directly contribute to taking the site's safety, quality, delivery and cost metrics to the next level.
Duties & Responsibilities:
Collaborate cross-functionally to resolve difficult quality problems on products, processes, or materials for manufacturing, new product development and suppliers
Perform investigations and resolution of validation failures, process deviations, abnormal results, complaints and quality inquiries and other quality performance indicators
Assist in the development and implementation of product and process quality plans and inspection and testing strategies. Provide support for the implementation of process and product qualifications and validations
Assist in the development and implementation of quality programs, including analyzing and problem solving including proposingsolutions/improvementsas well as execution of these proposals
Assist in the day-to-day operations of the Corrective and Preventive Actions (CAPAs) system and implement CAPA plans
Provide direction on test methods and protocols to ensure verification activity is adequate to assure the safety and efficacy of the device for product development and quality conformance teams
Support supplier capability assessments by analyzing performance data, facilitating problem-solving activities and developing suppliers' capabilities in quality tools and techniques.
Support supplier audits and new supplier qualifications by performing verification and validation activities and solving process and design problems
Support new product development teams by developing and implementing product quality plans, quality specifications,verification/validationprotocols and reports and other documents
Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices
Requirements:
Bachelor's degree in Engineering required, preferably in Mechanical Engineering or Biomedical Engineering
Basic understanding of problem solving and quality improvement tools and techniques
This position is not eligible for employer based visa sponsorship
Benefits:
CONMED offers
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, 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.