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Quality Assurance Engineer in Springville, UT at ConsultNet

Date Posted: 4/29/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    4/29/2019
  • Job ID:
    19-00889

Job Description

Job Title: Quality Assurance Engineer
Location: Springville, UT
Duration: Contract to hire, long-term
Pay range: $28-$32/hr DOE
 
Job Responsibilities:
Participate as a member of cross functional teams to address advanced quality planning activities in Medical Device Contract Manufacturing environment including Risk Management, ORT, pFMEA, Supplier Selection and Qualification, Inspection Plans, and Control Plans supporting new product launches.
Participate as a member on business teams to address Corrective and Preventive Corrective Actions using brainstorming, 5-Why, Cause & Effect and other proven problem solving techniques to deliver problem solving methods to the factory products and processes.
Assure consistency of the Product Inspection methods and criteria across the enterprise leveraging statistical techniques and Measurement Systems.
Review site CAPA process including formal, effective and detailed reviews to assure the business makes progress in problem solving with verification of corrections and tracking of results.
Participate as a member in the NCMR & MRB process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results.
Participate as a member of cross functional engineering teams to apply Process Validation methods based upon Risk Management processes in a Contract Manufacturing environment.
Deliver Customer confidence thru well performing systems with objective evidence of records and Customer Satisfaction thru product and service results,
Participates as a member on Quality team to improve the site Quality Management Systems (QMS) demonstrating compliance to ISO standards and FDA regulations (cGMP) for a full-service site including interfacing with procurement & engineering activities.
Job Requirements:
BS in a technical / scientific discipline such as Mechanical, Electrical, Electronics, Manufacturing or similar technical degree.
2+ years of progressive experience understanding and using the elements of ISO 13485 QMS processes, USA FDA part 820 regulations
Experience with Sterilization.
Significant exposure to REACH, RoHS, WEEE and Conflict Minerals compliance
Experience preparing for and hosting customer and regulatory audits and inspections
Ability to read, analyze, and interpret complex documents.
Ability to respond effectively to the most sensitive inquiries or complaints.
Ability to interface effectively with fellow employees, customers, sales and executive leadership.
Strong Interpersonal and team building skills required.
 

Be a part of the ConsultNet difference. As a leading national provider of Engineering and IT staffing and solutions, ConsultNet delivers exceptional services to startup, midmarket and Fortune 1000 companies across North America. Since 1996, we've partnered with clients to create rewarding opportunities for our consultants, successfully building teams that have surefire results.
In the past two years alone, we have placed more than 1,500 consultants in contract, contract-to-hire, or direct placement opportunities. We understand communication is key to finding the right job that matches your skills and career goals. For us, it's not just the work that we do; it's how we do the work. Our breadth of offerings extends to multiple IT positions in major markets throughout the country, see more at www.consultnet.com