Supplier Quality Engineer - - (queensbury NY & Marlborough MA Locations)

AngioDynamics Supplier Quality Manager

Join a team committed to improving patient care. It takes a team of talented people to become one of the world’s leading providers of innovative medical devices. AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care. We accomplish this through a commitment to the highest standards of quality, relentless innovation, and operational excellence. Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry. We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

Job Summary

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This position is responsible for improving supplier performance and developing a quality global supply base through routine supplier monitoring, issue investigation, and corrective action implementation. This position will also be responsible for leading or assisting with supplier validation and remediation activities.

Essential Duties and Responsibilities

• Take the lead to develop and qualify suppliers for the purpose of meeting rapid and ever-changing production activity.
• Perform supplier selection, evaluation, and qualification activities per established procedures.
• Have a firm understanding of production schedules and needs to ensure that suppliers are prepared to meet capacity needs.
• Ensure sourcing strategy and quality expectations are clearly understood, accurately received, and appropriately implemented at supplier level.
• Continually evaluate supplier quality performance, identify problem areas, and implement supplier corrective actions as required.
• Perform regular supplier oversight activities including supplier audits; report on findings to appropriate business partners.
• Represent AngioDynamics in a professional and objective manner at all times when partnering with outside suppliers and cross-functional partners.
• Lead internal supplier-related process improvement activities.
• Assure Supplier Corrective Actions (SCAR) are developed and executed in a timely manner by assigned suppliers via robust quality techniques.
• Support completion of Supplier/Component Approvals with suppliers for assigned legacy/NPI parts.
• Coordinate and resolve Supplier Change Requests with cross-functional resources in a timely manner.
• Interface with Suppliers, Engineering, Service, Manufacturing, and Sourcing to drive supplier improvements that minimize the Cost of Quality; specifically, Field Failures, and supplier-caused factory defects.
• Partner closely with Quality and Regulatory functions to resolve supplier-related complaints, CAPA’s, field change orders (FCO) and recalls.
• May perform other duties as assigned

Qualifications

The requirements listed below are representative of the knowledge, skill, or ability required.

• Education and Experience: Bachelors Level of Degree in the engineering or related field of study. Equivalent work related experience acceptable in lieu of degree.
• X Yes No 2-5 years of demonstrated experience in manufacturing preferably in design, quality or regulatory assurance.
• Auditor and/or Lead Auditor Certification(s) preferred.
• Any preferred education, experience or certifications: Six Sigma green belt, black belt or quality certification preferred.

Skills/Knowledge:

• Effective problem solving, root cause analysis and technical/engineering skills to lead and influence change.
• Medical Device industry experience and knowledge of FDA/ISO 13485/QMS/cGMP regulations.
• Knowledge of injection molding and extrusion a plus.
• Lead Auditor training and knowledge of advanced audit practices preferred.
• Strong demonstrated knowledge of PFMEA, 8-D, PPAP, APQP or other root cause problem solving methods.
• Strong leadership, conflict resolution and negotiation skills required.
• Proficient in the following computer software applications: Microsoft Office.
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports, QMS procedures and correspondence.
• This position requires some travel up to 25% of the time.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.
• The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
• AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.
• Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.