SR QUALITY ENGINEER
Company: TE Connectivity Ltd.
Posted on: February 23, 2021
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 TE's Medical business
unit, part of the Industrial Solutions segment, offers medical
device OEMs, a complete product offering, and capability portfolio
for minimally invasive, imaging, surgical, diagnostic, and
therapeutic devices. With more than 350 design engineers and a
global presence in all key medical device hubs, we are a premier
partner to the world's leading medical technology companies for
their next-generation medical devices. We are experts in all
aspects of device design and manufacture, from access & delivery
solutions for interventional medicine; to sensors & connectors for
surgical applications. Our innovative solutions enable ground
breaking medical therapies such as treating heart disease without
opening the body, placing microscopic devices into brain arteries
and powering robotic surgery.The senior quality engineer will focus
on one of TE Medical's value streams, working with manufacturing
teams to sustain and improve manufacturing quality on Class II and
III medical devices. You'll utilize your statistical strengths in
SPC-implementation projects, increase efficiencies using continuous
improvement methods, and interact with the customers frequently Job
- Investigation of root cause and following through on effective
corrective actions to prevent reoccurrence for the customer and
internal quality issues.
- Establishing inspection standards, plans, frequencies and test
- Establishing and maintaining FMEA's.
- Preparing and updating Operations procedures and associated
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The Senior Quality Engineer will perform an active role in
quality planning and new product introduction from a quality
- Maintain relevant documentation to comply with quality
standards and customer requirements.
- Quality review of responsible area validation
- Performing an active role in further development and continuous
improvement of the quality management system.
- Will assist in issues related to Metrology, Inspection,
Testing, Product stability, and vendor certification programs.
- Participates with the Director / Manager in the preparation of
divisional, departmental, and project goals.
- Assists the Director / Manager in presentations of technical
nature when requested.
- Ensure that every product and service we supply conforms to FDA
and Quality System Regulations as well as EN46001/ISO13485/MDD
Standards. What your background should look like:
- BS/BA degree with a scientific emphasis required
- Min. 5 years' experience as quality engineer
- Good working knowledge of ISO/FDA/MDD and other Product
Development related regulatory requirements.
- ASQ Certified Quality Engineer preferred Six Sigma Green/Black
belt preferred Quality experience in component and device
- Excellent written and oral communication skills essential.
Competencies Values: Integrity, Accountability,Teamwork, Innovation
Location: PLYMOUTH, MN, US, 55442 City: PLYMOUTH State: MN
Country/Region: US Travel: None Requisition ID: 64242 Alternative
Nearest Major Market: Minneapolis
Job Segment: Quality Engineer, Senior Quality Engineer,
Manufacturing Engineer, Engineer, Engineering, Quality
Keywords: TE Connectivity Ltd., Plymouth , SR QUALITY ENGINEER, Engineering , Plymouth, Massachusetts
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