Job Responsibilities
One or more hours/day Material Review Board (MRB) participation.
4 - 6 hours/week Complaint Review Board (CRB) activity as needed.
One hour/day on Corrective and Preventive Action (CAPA) closure
as needed. One hour/day or more Operations Quality (floor)support
as needed. One hour/day for Change Request initiation, review
and/or approval as needed. One hour/day Administrative (Filing,
Meetings, etc.). Audit participation (Internal, External or Third
Party) as needed (about 2Hr/month). Six Sigma Project support
through Problem Solving and DMAIC (Define, Measure, Analyze,
Improve and Control) techniques (an hour/day average). Supporting
Barrier Removal Teams (BRTs) to improve/update processes (2-5
hours/Week).
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Job Requirements
Undergraduate degree in an Engineering Discipline or equivalent
is the minimum.Having Quality background experience is a plus.
Professional Certification(S) also a plus.
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Uppers
Project Related Work (direct and indirect), Statistical Analysis, Complaint
Evaluations.
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Downers
Sometimes too many meetings, dealing with other people's personal
agenda items, writing/documenting justifications for calibrated
equipment that is found to be Out of Tolerance (OOT.
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Lifestyle
Work hours are around 50 to 60 hours/week (realistically). There is about a 5%
amount of Business Travel involved overall. The company: Schedules Quarterly
Business Unit (QBU) meetings with all employees; Supports participation in
various charitable events throughout the year; Holds an "Employee Recognition
Day" in the fall and "Holiday Dinner/Dance" at year end. Dress code is business
casual generally. Employee base contains individuals from Hispanic, Pacific Rim,
Far Eastern, Native American and many other backgrounds. It is truly a "melting
Pot" culture.
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Compensation
Base Salary is approximately $70K. Year end performance bonuses
can be upwards of $10K in salary and 5% in Stock Options.
Vacation is 3 weeks to start with and requiring about 6
individual days being used during winter shut down. Very
competitive cafe style employee benefits package that includes
optional dental and optical insurance.
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Advice to Jobseekers
Take good practical Statistics courses. Read trade journals in
the Medical Device field. I think Medical Devices will only
become more prolific as time moves on. The entrepreneurial world
is constantly adding "new" widgets here.
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