Quality Specialist
Job
Actalent
Eden Prairie, MN (In Person)
$71,372 Salary, Full-Time
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Job Description
Job Title:
Quality Specialist Job Description The Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of various standards such asIS0 9001, ISO, MDSAP, FDA 21 CFR
Part 820/211, EU MDR, and other applicable standards. This role involves supporting complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement through the use of statistical techniques and other accepted quality principles. The position also encompasses activities concerned with the development, implementation, maintenance, and continuous improvement of quality systems. Responsibilities Participate on cross-functional new product development teams with a focus on product/service quality and Quality System compliance. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis. Initiate and/or participate in process and product corrective actions and problem-solving activities. Update and establish documented work instructions as needed. Review collected data to perform statistical analysis and recommend process/product changes to improve quality. Monitor and report on performance metrics. Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials. Perform quality system audits and provide guidance on corrective actions. Essential Skills Quality assurance Reporting Immediate inspection needs CAPA investigation DTS Assessment SPEC updates for ongoing clarity and CIO (inspection reduction) Additional Skills & Qualifications Backup NCMR Coordinator with QEs transferring department Proficiency in Excel BS in Technical Field 2+ years of experience in Quality Engineering/Quality Systems 2+ years of experience with medical device or other regulated industries ASQ, QSR or familiarity with QSR/GMP regulations preferred Work Environment The work environment is structured and clean, with work conducted onsite. The company offers a large company backing with a small company feel, providing a flexible environment and long-term opportunity and vision. Job Type & Location This is a Contract position based out of Eden Prairie, MN. Pay and Benefits The pay range for this position is $28.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Eden Prairie,MN.
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