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SUPPLIER QUALITY ENGINEER

Tecomet, Inc.
Wilmington, MA
  • Posted: October 23, 2022
  • Full-Time
POSITION SUMMARY

The Supplier Quality Engineer is responsible for managing supplier quality, and leader of the CAPA program for supplier non-conformances. Coordinates and drives improvements in quality, cost, and delivery. Extensive knowledge of quality system requirements ISO 13485 & CFR 820. Relies on experience and judgment to plan and accomplish goals. Works independently with minimal supervision.

PRINCIPAL RESPONSIBILITES
  • Supports supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities.
  • Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
  • Supports design, development, and manufacturing operations toward implementing changes within the supply base by leading the change control process for dedicated Tecomet facilities.
  • Partners with suppliers to establish and maintain controlled manufacturing processes.
  • Facilitates root cause analysis and corrective actions for supplier quality issues (SCARs).
  • Report supplier quality trends, performance, and other information to leadership.
  • Assists in contract/order reviews.
  • Leads efforts to reduce supply base in coordination with other Tecomet facilities.
  • Participates in design review for the purpose of working with suppliers to establish and maintain robust/rigorous measurement methodologies.
  • Supports supplier validation activities by assisting with FMEA's and Control Plans., Special Process Validations
  • Performs internal audits to ensure quality compliance.
  • Utilize Tecomet Supplier Portal / Intranet for real-time metrics tracking with supplier.
  • Maintain supplier quality document repository
  • Perform supplier performance reviews and maintain supplier audit schedule as required.
  • Assists in other Quality Engineering duties as needed.
  • Travel up to 50% may be required.


REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
  • Regulatory cGMP, QSR and ISO knowledge base preferred.
  • Computer literate/proficient with Microsoft Office applications.
  • Negotiation and problem-solving skills.
  • Good oral and written communication skills; ability to properly speak and write in the English language.
  • Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R).
  • Experience in the area of manufacturing operations preferred.
  • Ability to multi-task, prioritize and work independently.


EDUCATION AND EXPERIENCE
  • B.S. degree in Engineering preferred, or equivalent experience.
  • Minimum of three (3) years with medical device experience in manufacturing operations, process qualification, and/or quality engineering preferred.
  • ASQ Certification a plus.


PHYSICAL DEMANDS

While performing the duties of this job the employee is frequently required to stand, sit, walk, talk, and hear. The employee is occasionally required to reach with hands and arms, stoop, kneel, or crouch.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MISCELLANEOUS:

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and the employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Tecomet, Inc.

Address

Wilmington, MA
01887 USA

Industry

Manufacturing

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