Supplier Quality Engineer II

FHLB Des Moines; Largo (FL); On-site; USD 75,000 - 105,000; Full time

Job summary

CONMED is seeking a Supplier Quality Engineer II to provide quality engineering support across design, procurement, assembly, test, and manufacturing of medical devices, ensuring compliance with customer and regulatory requirements.

You will investigate supplier-related issues, coordinate with cross-functional teams, and help implement robust quality systems and CAPA across the lifecycle of products, from design through sustaining, while contributing to regulatory compliance and supplier

Qualifications

• Bachelor’s degree in Engineering or related discipline and 2 years in quality engineering.
• Knowledge of QSR, ISO14971, AAMI IEC 62304-2006 and ISO 13485 preferred.
• Certified Quality Engineer and Certified Quality Auditor preferred.
• Strong problem-solving and data-driven decision-making abilities.

Responsibilities

• Investigate supplier-related process and product issues with cross-functional teams.
• Plan, schedule, and coordinate engineering activities to meet project milestones.
• Support design and manufacturing process quality systems and CAPA efforts.
• Provide guidance on QA tools and regulatory compliance throughout the product lifecycle.

Skills

Quality engineering

Root cause analysis

DMAIC

Statistical methods

Process improvement

Education

Bachelor's degree in Engineering or related discipline

Tools

DMAIC

Quality tools

Quality management systems

CQE

CQA

Job description

Supplier Quality Engineer IIThe Quality Engineer II will provide quality engineering support to all functions for the design, procurement, assembly, test, manufacturing, validation, and distribution of medical devices, processes, and quality systems to ensure that all CONMED products are in full compliance with customer and regulatory requirements. This role will focus on supplier quality engineering activities.Key Duties and Responsibilities:Investigate supplier related process and product issues as assigned by supervisor. Work with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.Plans and performs engineering assignments. Coordinates engineering personnel and the activities of the particular group with the various stages of the overall program.Plans, conducts, and supervises engineering assignments, normally involving several smaller or one major project.Schedules work to meet completion dates and technical specifications.Estimates and coordinates personnel needs assigned to projects.Reviews progress and evaluates results. Review and analyze system and requirements specifications. Review and analyze supplier systems and design specifications.Supports development, implementation and maintenance of design and manufacturing process quality systems.Supports corrective and preventive systems, ensuring investigations through to root cause in accordance with other departments.Consults and provides guidance to Design and Manufacturing Engineers and Procurement Professionals, on the use of Quality Assurance tools, ensuring robust quality systems throughout the lifecycle of a product, from design through sustaining.In addition to the main responsibilities listed above the manager is allowed to use discretion to add further duties and tasks based on the business needs which are not explicitly listed here.Required Experience: Bachelor’s degree in Engineering or related discipline 2 years of related experience in quality engineering or related fieldsPreferred Experience:Fundamental understanding of quality philosophies, principles, systems, and methods.Knowledge of management and planning tools, quality tools, preventive and corrective actions, DMAIC, statistical principles and how to overcome barriers to quality improvements.Knowledge of the QSR, ISO14971, AAMI IEC 62304-2006 and ISO 13485.Certified Quality Engineer and Certified Quality AuditorExpected Travel 0-20%This position is not eligible for employer-visa sponsorshipBenefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance - cost paid fully by CONMEDRetirement Savings Plan (401K) - CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan - allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow 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 and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms 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 800-929-7176 option #5.