Principal Supplier Quality Engineer

JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

This position supports the Sr. Supplier QA Manger in developing strategies and managing the activities within the Supplier Quality dept. Responsibilities include improving supplier performance and developing a quality global supply base through routine supplier monitoring, issue investigation and corrective action implementation, as well as the sustaining of supplier metrics to ensure supplier management requirements are met.

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.

• Work closely with contract manufacturers to develop a partnership and manage all quality activities.

• 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 but not limited to supplier audits; report on findings and follow-up, and engagement with appropriate business/supplier 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 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, and recalls.

• Specify and purchase new test equipment as required for incoming inspection of purchased materials

• Qualification of new material / component suppliers

• Represent supplier quality at Project Reviews

• Provide statistical support as needed for evaluation of purchased material

• Create / submit change orders to support changes to purchased material or incoming inspection processes

• Evaluate and disposition non-conforming purchased material

• Assist Incoming Inspectors with inspection methods and evaluation of purchased product as needed.

• Mentor team members as required; Provide guidance and support to the Supplier Quality team, and assist Design Controls project teams.

• Lead meetings for the review of NCRs, SCARs and related metrics

• Periodic review and revision as needed to supplier quality related procedures to reflect business practice changes and to streamline processes

• Develop and/or assist the creation of Incoming Inspection Op Codes as needed

• Investigate opportunities to reduce Incoming Inspection requirements and/or utilize supplier data to reduce cost and support skip lot, or dock-to-stock program.

• Drives harmonization and best practices across suppliers primarily contract manufacturers.

• Assist Sr. Supplier QA Manager to properly escalate significant issues when warranted.

• 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 and//or related field of study.

• 10-12 years of demonstrated experience in QA/RA preferably in design, quality or regulatory.

• 7 years of Medical device industry experience preferred. Knowledge of FDA/ISO 13485/QMS/cGMP regulations required

• 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.

• Knowledge of medical device contract manufacturing finish good supplier relationship preferred.

• 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.

• Ability to operate independently.

• Proficient in the following computer software applications: Microsoft Office, Agile, Oracle

• Exceptional interpersonal skills.

• Strong organizational skills.

• Strong communication skills (written and verbal).

• Ability to effectively communication 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 and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.

• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.

• Exposure to standard office environment

• Ability to frequently lift and/or move up to 15lbs

• Ability to occasionally lift and/or move up to 50lbs

• Ability to regularly sit or stand for extended periods of time

• This position requires some travel up to 20% of the time