Job Posting
Quality Engineer
We are Medical Instrument Development Laboratories, Inc.
(<
http://www.midlabs.com/>www.midlabs.com), a leader in development
and manufacture of specialized ophthalmic surgical devices. We are
an established revenue-generating company.
POSITION SUMMARY:
You are a self-starting, detail oriented, quick learning, creative,
analytical capable of multi-tasking and rapidly adapting to changing
priorities, who will work closely with the MID Labs VP of QA & RA,
Engineering, R&D and Manufacturing teams to support design
activities, validations and audits while motivating and educating
company personnel to help create a quality culture.
REQUIRED EXPERIENCE:
Minimum five years related experience in the medical device field desired.
Familiarity with FDA's Quality Systems Requirements (QSR) and ISO 13485:2003.
Experience in Risk Management per ISO 14971.
Excellent communication and time management skills.
Attentive to details.
EDUCATION:
BS in an Engineering discipline or equivalent.
ASQ Certification (CQE) preferred.
ADDITIONAL SKILL AND EXPERIENCE DESIRED:
Support and improve company Quality Systems.
Ability to write routine reports and correspondence.
Support risk management activities in including hazard analysis and FMEA.
Support investigations and resolutions of product complaints and/or
safety issues.
Lead effort in resolution of non-conforming materials activities in MRB.
Administer CAPA program.
Coordinate and develop effective inspection and testing activities.
Facilitate lot release testing and sterilization review activities.
Establish and maintain statistical sampling methods for inspection activities.
Ability to read and interpret documents including drawings (including GD&T).
Fluent in the proper selection and use of measurement system.
Ability to speak Mandarin preferred.
Please reply via FAX to 510-740-4442 or by email
<mailto:hr_at_midlabs.com>hr_at_midlabs.com
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listed in the posting. Please do not "reply" to the posting messages.
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Received on 2013-01-07 15:13:23