Location: Brooklyn Park, MN 55428
Duration: 06+ Months
Must have medical device background
Job Function: Summarize the function(s) of the job and reflect the basic purpose of why the position exists.
Perform inspections, checks, tests, and sampling of incoming materials, in-process inspections, and finished goods inspection. This position is responsible for practicing Quality System procedures and complying with its requirements, and carrying out responsibilities as outlined in product specifications and company procedures.
The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.
100 Perform inspections or tests of purchased parts according to well-defined criteria using standard physical, mechanical, and/or electrical measurements and accurately document results. Rework or reject subassemblies or finished products as required. Complete Material Review Authorization Form as needed. Review travelers for completion and accuracy. Complete device history record review.
High School graduate or equivalent required.
Knowledge of QSR, MDD, ISO 13485:2016, CMDR.
Minimum of 2 years’ experience, preferably in the medical device industry.
Computer literacy and experience using sampling charts, a basic understanding of statistics.
CMI, CQT preferred
Strong working knowledge of basic Quality Assurance
Strong computer skills in Microsoft Office (including Word, Excel, Outlook)
The organization, interpersonal, and communication skills
Self-directed, resourceful, detail-oriented and able to manage multiple priorities
Able to work in a fast-paced and results-driven environment
Ability to read, write and comprehend English
Physical Requirements: Physical requirements for a position will vary. These must be reviewed with the supervisor and should be attached here.
Must be able to remain in a stationary position 75% of the time.
The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, etc.
Constantly operates a computer and other office productivity machineries, such as a calculator, copy machine, and computer printer
The person in this position frequently communicates with internal and/or external contacts. Must be able to exchange accurate information in these situations.
Requires clarity of vision at 20 inches or less (near vision) and the ability to identify/distinguish colors.
Significant work pace & pressure due to deadlines.
Light work, exerting up to 20 lbs of force or less.
Requires fingering, repetitive motion, talking and hearing.