Quality Engineer I

Mounds View, MN, US • Posted 11 days ago • Updated 11 days ago

Contract W2

Contract Independent

Contract Corp To Corp

On-site

$35 - $37/hr

Talent Software Services, Inc

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

POST MARKET
POST-MARKET SURVEILLANCE
POST-MARKET
DATA ANALYSIS
HAZARD ANALYSIS
RISK ASSESSMENT
RISK MANAGEMENT
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

Quality Engineer I

Job Summary: Talent Software Services is in search of a Quality Engineer I for a contract position in Arden Hills, MN. The opportunity will be for one year with a strong chance for a long-term extension.

Position Summary: This quality engineer role will investigate product complaints and monitor the client''s product performance. The team uses product performance data and deep dive analysis to understand if products are performing as intended. Escalating post-market field performance signals to better understand what the data is telling us, collaborating with cross-functional teams to mitigate risk, focusing on patient safety and improving product performance. This role doesn''t touch product - more data-related responsibilities.

Primary Responsibilities/Accountabilities:

Embodying the client''s Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, and Winning Spirit.
Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.
Performing complaint investigations in accordance with local and global processes.
Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.
Responding to Competent Authority Requests.
Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through the sales organization.
Providing input for process improvement and helping develop tactical approaches to implement team strategies
Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.
May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources; Identifies and leads cross-functional project teams comprised of functional experts and local managers.
Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.
Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Qualifications:

BS required with 1-3 years of relevant experience.
A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.
Understanding and a command of highly technical engineering topics and applied statistics.
Ability to independently manage project work to define and consistently meet delivery dates.
Understanding and experience operating within quality system processes and procedures.
Strengths in communication (verbal and written) and data analysis skills.

Preferred:

Engineering Degree with 2+ years of relevant medical device experience.
Strong technical understanding of medical device therapy products.
Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
Strong Technical Writing skills.
Experience with the quality system escalations, CAPA investigations and field assessments.
Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.
Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.

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: 26-03005
Posted 11 days 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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Quality Engineer I

Talent Software Services, Inc

Dice Job Match Score™

Job Details

Skills

Summary

Embodying the client''s Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, and Winning Spirit.

Reviewing completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.

Performing complaint investigations in accordance with local and global processes.

Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.

Responding to Competent Authority Requests.

Company Info

About Talent Software Services, Inc

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