Quality Engineer II, Complaints


工作内容: Quality Engineer II, Complaints

Our client is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. The company vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services.

The primary purpose of
this job is to execute and support the Complaint Handling and regulatory
reporting processes under the direction of the Quality Systems Engineer. This
position will also be responsible for participating in development of processes
that comply with published regulatory requirements. This position will also
conduct detailed quality analysis and trending of data.

Key Accountabilities
and Responsibilities

1. Adheres to company
values and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S.
Food and Drug Administration (FDA) regulations, Company policies and operating
procedures, and other regulatory requirements.

2. Responsible for
supporting and performing customer complaint investigations by working in
collaboration with Operations, Quality and R&D associates to facilitate the
completion of complaint investigations in a timely manner and determining need
to escalate issues.

3. Reviews test
procedures and plans related to complaint investigations prior to executions,
conducts failure analysis and inspection on products, processes and materials

4. Responsible for
completion of Medical Device Reports (MDRs) and Medical Vigilance Reports
(MDVs) determination checklists.

5. Responsible for
completion of applicable forms for submission of reportable complaints to
applicable agencies.

6. Responsibly for
metrics coordination and reporting to manager.

7. Provides Quality
Systems and Compliance consulting to Operations associates related to Complaint
Investigations, and other compliance topics.

8. Independently
performs assignments, receiving instruction only regarding general expected results.

9. Assists with
quality assurance functions in support of needs directed by Quality Management.

10. Performs other
functions as required.


Minimum Education: Bachelor’s degree in a related field or equivalent amount of work experience

Minimum Experience:

Bachelor’s degree with 3-5 years of experience in Quality Assurance and Compliance or 6-10 years of experience within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry.

Specialized Knowledge:

Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.

Special Skills:

Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.


Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

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Account manager

Max Schumacher
Brunel USA - Minneapolis