Quality Management Systems Specialist
We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.
Work Schedule : 1st Shift M-F 7 : 00AM-3 : 30PM
Benefits :
- Medical, dental, and vision benefits effective on date of hire
- Generous paid time off benefits and 10 paid Holidays
- 136 Hours PTO (prorated based on hire date)
- Company-paid life insurance
- 401k plan with company match
Well-Being :
Low-cost nutrition and mental health visitsUp to $150-off your gym membership annuallyDiscounted Pet Insurances for your furry friendsAccess to individualized financial planning meetingsEmployee Discount Program with savings on electronics, home goods, gym equipment, and moreDiscounted family caregiving supportCareer Growth :
Tuition ReimbursementOn-site Training ProgramsDefined Career Path for advancement in role and compensationNew Hire On-boarding Training PlansOur top-notch work environment includes :
Climate Controlled.Clean & Comfortable SettingPosition Summary :
This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols. Manage DHRs, Labeling and visual inspection.
Job Responsibilities :
Maintain organized workspace and perform line clearance activities consistently.Manage daily workload under minimal supervision to meet expect personal / department goals.Communicate with co-workers respectfully and professionally.Complete required documentation and inspection operations with detail, accuracy, and precision.Maintain the focus needed to complete tasks in a timely, efficient, and accurate manor.May help train new employees as requiredGenerates shipping label lots and label trace-sheets.Simple visual and measurement inspections (in-process, incoming, final)Scans DHR and receipt travelers.Review DHR'S and receipt travelers.Read and follow quality work instructions.Support MRB investigations.Review Quality Work Instructions and update / improve as needed.Other duties as required.Job Requirements :
Knowledge / Education :
High School diploma or equivalent. Associate's Degree in a technical field or other related degree preferred.Experience :
3+ years of experience in manufacturing environment preferred.Skills / Competencies :
Detail oriented with an ability to solve problems.Excellent written and verbal communication skills.Ability to read and interpret blueprints to determine set-up and operations.Proficient in blueprint reading. Basic GD&T knowledge.Proficient in machine shop math (i.e. fractions to decimals, metric conversion and sampling plans.Understanding of problem solving and specification requirements in relationship to the gage used and the part tolerance.