SENIOR QUALITY engineer
OncoStim,
Inc. is a privately held medical device company developing medical devices for
ablating benign growths and cancerous tumors.
General Summary
The Senior
Quality Engineer participates in all quality assurance activities related to medical device
development. This position will manage the execution of multiple projects, interfacing with
engineers, suppliers, and regulatory personnel.
Position Responsibilities
- Work with consultants or contract personnel in
developing a quality system that conforms with FDA QSR and ISO 13485
- Assure that product development is performed in
compliance with SOP’s
- As part of the product development team, review
design documents including specifications, risk analysis, FMECA, test
plans, procedures, and reports
- Develop and maintain a corrective and preventive
action system
- Help with the selection of suppliers and contract
manufacturers
- Work with suppliers and contract manufacturers to
improve quality
- Assist with administration of document control
system
- Provide assistance with the preparation of
regulatory submittals
- Frequent contact with engineers and regulatory
personnel
Educational / Experience Requirements
- Bachelor’s degree in
engineering
- 5+ years of quality
engineering experience in the medical device industry
- Experience with medical device product development
- Knowledge of FDA quality system regulations
- Demonstrated project
management and problem solving skills
- Hands-on individual who can function effectively
in a technological, entrepreneurial environment
- Self-starter who is comfortable assuming
responsibility
- Excellent
communications skills
- Strong
organizational and interpersonal skills
If you have most of these
skills, we invite you to contact us to potentially be a part of developing
cutting edge medical device technology.
NOTE: This job description does not describe each
task and responsibility. However, the
Company believes that it has included the essential functions of the job. Management retains the discretion to add or
modify duties of the position and to designate other functions as essential at
any time.
Oncostim, Inc. offers a casual work environment that accentuates
innovation and results. We also offer
competitive salaries and benefits, including stock options and a 401(k) savings
program.
Fax
resumes to 763-463-4817 attn Human Resources or E-mail us at
kroll@oncostim.com.
You
may also send your resume via mail to:
Oncostim, Inc
Attn: Human Resources
6901 East Fish Lake Rd.
Suite 190
Maple Grove, MN
55369