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Do you have 2+ years of previous experience in QA or QC in medical device field? Our client in Plymouth is looking for a 1st shift Quality Assurance Inspector for a CONTRACT role ending in July 2023
RESPONSIBILITIES:
• The position will be in the cleanroom and be responsible for admin work.
• The quality inspector supports commercial production activities and provides inspection services and routine quality oversight of production processes to ensure product quality and adherence to procedural requirements.
• The quality inspector is a subject matter expert in quality inspection processes, cleanroom gowning and sanitation requirements, good documentation practice, production tools/methods and workflows. As such, he/she will be consulted to assist in root cause investigations and solution brainstorms when a quality issue occurs.
Nature & Scope of Position:
70% of Time:
• Perform quality inspection activities and provide quality support for cleanroom production.
• Review, inspect, and release of incoming materials.
• Identify and segregate nonconforming materials.
• Participate in MRB and coordination of control of nonconforming materials
• Participate in the investigation of customer complaints or other quality events, root cause analysis, and CAPA.
• Perform cleanroom environmental monitoring activities
• Collect process monitoring data
• Perform periodic internal audits on quality and safety.
• Support validation and process improvement projects
• Assist with in-house equipment calibration and maintenance activities
20% of Time:
• Act as SME for quality inspection and ISO 9001 requirements and assists in the training of employees.
• Participate in SOP/work instructions creation and revision.
• Have oversight of quality inspection areas to ensure proper levels of 5S are maintained
5% of Time:
• Carry out formulated plans, policies, and procedures of the department per ISO 9001 2015 requirements.
• Communicate with employees any instructions or requirements as deemed necessary by the Quality Manager.
• Be cross-trained and available to cover for co-workers when necessary.
• The individual will be seated for long periods of time at the computer, manufacturing, or inspection stations.
• May lift 25 lbs. On occasion. Reaching above shoulder height, below the waist, or lifting as required with proper lifting techniques.
• Specific vision ability required by this job includes close vision, color vision, and depth perception.
QUALIFICATIONS & SKILLS:
• Associate or bachelor's degree and two years related experience (QA or QC) in a regulated and ISO 9001-certified environment; or high school diploma with five years of experience.
• Strong organizational and communication skills, both written and verbal.
• Be able to read, write and understand English, and effectively communicate to Quality leadership and site management about quality issues.
• Be able to complete production paperwork and follow good documentation practice guidelines.
• Be able to follow SOPs, observe safety procedures and report unsafe practices or situations to management.
• Be able to work in a clean room environment.
• Strong ability to interpret an extensive variety of technical instructions, drawings, or blueprints.
• Proficient computer skills, including Microsoft Word and Excel.
• The work activities of this position are primarily in a production cleanroom (70%), and incoming material sections in the warehouse (20%), which require the use of personal protective equipment such as safety glasses and safety shoes. The remaining work activities (20%) is done in an office setting, where temperature, lighting, and traditional office equipment as found in a typical office environment are normal.
PAY AND BENEFITS FOR QA INSPECTOR
• Contract (until July 2023)
• Plymouth, MN (Northeast Metro area)
• Monday through Friday,
• 1st shift: 7-3:30 PM
• $20/hr.
• THE RIGHT STAFF offers Healthcare, vacation, and referral bonuses
APPLY NOW!
For immediate consideration please send resume to stp2@therightstaff.com
This position will require a background check.
THE RIGHT STAFF wants to help you succeed! Our team of seasoned professionals works to match you to the best job, best fit, and best location. Contract assignments to full-time permanent positions, we are here to assist you!
THE RIGHT STAFF is an Equal Opportunity Employer.