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Senior Quality Engineer

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  • Job
    Full-time
    Mid Level
  • Chicopee

Requirements

  • 4-year college degree in related field.
  • 3+ years’ experience in a Quality Engineering Role (preferably in medical device manufacturing).
  • 3+ years’ experience in the following: Oversight and approval of validation activities (IQ, OQ, PQ, MSA), oversight of and submittal of PPAP packages, participation in FMEA/PFMEA activities, Root Cause Analysis / CAPA, Internal Quality Audit, Supplier Quality, and Software Validation.
  • Good working knowledge of ISO 13485, PPAP, FMEA, AIAG Control Plan Methodology SPC, and Good Manufacturing Practices.
  • ASQC Certified Quality Engineer, preferred.
  • Proficiency in the use of Productivity Software such as Microsoft Office.
  • Ability to interact with all levels of the organization and with suppliers.
  • Strong written and oral communication skills.
  • Strong analytical skills in problem analysis and problem solving.
  • Strong leadership skills.
  • Occasional travel may be required.

Responsibilities

  • Oversees and approves IQ, OQ, PQ validation protocols, execution and reports on new and sustaining products.
  • Oversees PPAP activities and produces PPAP submittal packages on new and sustaining products.
  • Oversees Quality Technician function.
  • Participates as a member of the FMEA team related to primarily new and developing products.
  • Develops and documents control plans.
  • Conducts statistical capability studies and sets up SPC control charts.
  • Documents inspection procedures and test methods.
  • Performs regular audits of processes and materials to ensure that: Inspections, tests, and operations are being conducted and documented according to applicable specifications and standard operating procedures. Assures results of inspections and tests are in compliance with all applicable requirements.
  • Finalizes release of finished product based on above audits.
  • Monitors and interprets SPC charts to assure that processes remain in control.
  • Interfaces directly with production in the operator training process for quality issues.
  • Reviews reject reports and initiates corrective action as required.
  • Interfaces directly with other support departments as required.
  • Conducts special testing when required for failure analysis, validations, etc.
  • Sets up inspection / test equipment.
  • Develops and maintains Standard Operating Procedures.
  • Develops protocols, performs statistical analyses and writes reports for validations and formal product / process development.
  • Reviews and documents procedure changes for quality requirements and compliance with the quality system.
  • Provides audit support for third party audits, customer audits, and internal audits.
  • Provides technical guidance to the staff and mentorship to quality and manufacturing engineers.
  • Observes all safety regulations and procedures.
  • Follows all department and company policies and procedures.
  • Performs other similar duties as required by responsibility, necessity or as requested.

FAQs

Do we support remote work?

No, this position is on-site full-time in Chicopee, MA.

What is the main responsibility of the Senior Quality Engineer?

The Senior Quality Engineer is responsible for the development and implementation of quality systems for sealed plastic film products in an ISO 13485 environment, ensuring compliance with quality and regulatory requirements across multiple industries.

What qualifications are required for this role?

A 4-year college degree in a related field and 3+ years of experience in a Quality Engineering role, preferably in medical device manufacturing, are required.

Is experience in specific quality activities necessary?

Yes, candidates should have 3+ years of experience in oversight and approval of validation activities (IQ, OQ, PQ, MSA), participation in FMEA/PFMEA activities, Root Cause Analysis/CAPA, Internal Quality Audit, Supplier Quality, and Software Validation.

What certifications are preferred for applicants?

ASQC Certified Quality Engineer is preferred.

What software skills are expected for this position?

Proficiency in the use of productivity software such as Microsoft Office is expected.

Will travel be required for this role?

Yes, occasional travel may be required for this position.

What benefits does UFP Technologies offer?

UFP Technologies offers a competitive benefits package, including medical, dental, vision, life and disability insurance, a 401K with a matching contribution, paid time off, paid holidays, and employee discounts, among other offerings.

What is the company’s stance on equal employment opportunity?

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer, actively encouraging applications from minorities, women, veterans, and disabled individuals.

How can I apply for this job?

To apply for this job, you can create a profile through the company's online application system by clicking the "Apply" box in the upper right-hand corner, or you can use your LinkedIn, Google, or Facebook credentials if you already have an account.

UFP Technologies is a designer and manufacturer of medical devices, sterile packaging, and surgical robot drape systems.

Manufacturing & Electronics
Industry
1001-5000
Employees
1963
Founded Year

Mission & Purpose

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.