QLTY & RELIABILITY ENGINEER II

Wilsonville, Oregon
Full time
Posted
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TE Connectivity
Manufacturing & operations
10,001+ employees
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At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

This position is responsible for direct interaction and support and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis: This position will report to the Director/Quality Assurance. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

  • Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
  • Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
  • Develop and maintain the pFMEA process for manufacturing.
  • Support/participate in regulatory agency and customer quality audits.
  • Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
  • Participate in initiating non conformance report, Containment, root cause investigation, dispositions and implementation of CAPA .
  • Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
  • Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
  • Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
  • Provide quality engineering support to sending sites during project transfers.
  • Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

This role is from Monday to Friday 8 am to 5 pm.

Qualifications

  • BS/BA degree with a scientific/engineering emphasis required.
  • AQS Certified Quality Engineer or MS in Medical devices engineering, Engineering Management or Mechanical
  • Six Sigma Green/Black belt recommended
  • Minimum of 3 years’ experience with MS in a related regulated medical device environment. Catheter/MI experiences an advantage.

COMPENTENCIES:

To perform the job successfully, an individual should demonstrate the following competencies:

  • Values: Integrity, Accountability, Teamwork, Innovation
  • Excellent verbal and written communication skills
  • Ability to work independently
  • Ability to manage tight timelines and changing priorities
  • Excellent problem-solving techniques
  • Proficient with Microsoft office applications

PHYSICAL DEMANDS AND WORK ENVIRONMENT

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.

PHYSICAL DEMANDS:


  • Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
  • Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

WORK ENVIRONMENT:


  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.

Travel

This position may require 20 % travel between sites and customer or supplier locations as required, dependent on the needs of the organization

ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).

COMPENSATION

  • Competitive base salary commensurate with experience:$75,760 – $113,640 (subject to change dependent on physical location)
  • Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
  • Total Compensation = Base Salary + Incentive(s) + Benefits


BENEFITS

  • A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets