Supplier Engineer (SE)

Mounds View, MN, US • Posted 9 hours ago • Updated 9 hours ago

Contract W2

On-site

$40 - $50/hr

Talent Software Services, Inc

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

CAPA
CORRECTIVE ACTION
PREVENTIVE ACTION
IQ
OQ
PQ
TMV
INSTALLATION QUALIFICATIONS
OPERATIONAL QUALIFICATIONS
PERFORMANCE QUALIFICATION
TEST METHOD VALIDATION
ABBOTT
MEDTRONIC
GE HEALTHCARE
BECTON DICKINSON
STRYKER
BAXTER
JOHNSON & JOHNSON
BOSTON SCIENTIFIC
AVANDOS MEDICAL
SIEMENS HEALTHCARE
3M
CMR SURGICAL
DANAHER
INTUITIVE SURGICAL
FRESENIUS
ZIMMER BIOMET
EDWARDS LIFESCIENCES
ALCON LABORATORIES
ABLE MEDICAL DEVICES
MEDICAL DEVICE
MEDICAL DEVICES
MEDICAL DEVICES COMPANY
MINNETRONIX MEDICAL
RESOLUTION MEDICAL
TACTILE MEDICAL
CIRTEC MEDICAL
ZURICH MEDICAL
NEU MEDICAL
SWITCHBACK MEDICAL
CLARUS MEDICAL
FREUDENBERG MEDICAL
ACIST MEDICAL SYSTEMS
TE CONNECTIVITY
NEXTERN
COLOPLAST

Summary

Supplier Engineer (SE)

Job Summary: Talent Software Services is in search of a Supplier Engineer (SE) for a contract position in St. Paul, MN. The opportunity will be for six months with a strong chance for a long-term extension.

Position Summary: This project addresses a CAPA related to the client's requirement to properly link design risks and design outputs to manufacturing processes performed by external suppliers. In this role, the Supplier Engineer will work closely with the client design team to identify the key design outputs that are critical from a design-intent perspective. They will then collaborate with Sustaining Supplier Engineering (SE) and Quality Engineering (QE) to gather existing process validation documentation from suppliers. The team will review these validation packages against criteria developed from the design output list to determine whether each supplier meets the client's minimum requirements. When gaps are identified, the engineer will partner with both the supplier and client sustaining teams to remediate deficiencies, improve validation or documentation, and ensure alignment with client expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed. This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for the client's contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with client's team members and CM SFMD suppliers to execute deliverables according to business needs. Build Quality into all aspects of their work by maintaining compliance with all Quality System requirements.

Primary Responsibilities/Accountabilities:

Review, remediate, and approve CM SFMD supplier's process risk documentation (PFMEA) to newly defined criteria.
Review, remediate, and approve CM SFMD supplier's process and inspection validations to client's statistical requirements.
Perform change management activities to remediate gaps found in CM SFMD Supplier's process risk documentation and process/inspection validations.
Collaborate with CM SFMD suppliers and client functional resources to complete all activities needed to approve the supplier's process risk documentation and process/inspection validations to the newly defined criteria.
In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Qualifications:

Bachelor's degree in engineering
1 – 2 years of experience in a manufacturing environment.
Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
Ability to travel up to 15% of the time (mostly domestic, could be international).

Preferred:

Experience working with suppliers or in supply chain management.
Experience working in the Medical Device Field.
Excellent communication and project management skills.
Strong bias for action and results-oriented.
Self-driven and self-motivated to learn and apply knowledge to produce results.
Good understanding of statistical methods, Six Sigma methodologies, and problem-solving methodologies.

If this job is a match for your background, we would be honoured to receive your application!

Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: talmn001
Position Id: 26-02164
Posted 9 hours ago

Company Info

About Talent Software Services, Inc

We pride ourselves in making sure that diversity in the workplace is at the forefront of our business. Our Founder, Dave Iacarella, is an Army Veteran who is committed to giving back to fellow Veterans. We are proud of our history of transitioning military Veterans into the workforce with companies that value their service. TALENT helps companies meet their veteran and diversity spend initiatives and requirements. We are committed to supporting veteran and diverse organizations.

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