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  • ID
    #9863279
  • Job type
    Contract
  • Salary
    TBD
  • Source
    Experis
  • Date
    2021-02-21
  • Deadline
    2021-04-22
 
Contract

Vacancy expired!

Job Title: Quality Engineer

II (Medical Device exp)

Job Location: Plymouth, MN / St Paul, MN Duration: 12+ Months (extension)

Description:

Quality Engineer II - Job Title Main Responsibilities - A Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within quality system/services support. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. Job Responsibilities - Responsible for implementing and maintaining the effectiveness of the quality system. Demonstrated writing and communication skills are required for this position. A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed. Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner. Execute and provide on-time completion of Quality Assurance (QA) engineering deliverables. Execute and provide on-time completion for assessment and implementing actions when deemed appropriate for regulation and standards updates. Maintains awareness of standards that regulate our industry. Support Global CAPA team with training, CAPA oversight, and CAPA deliverables. Support decision making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems. Provides data and quality metrics that feed into quality investigations, management reviews, and ad hoc presentations. This data will be used as objective evidence to support decision making, to drive action, and in order to aid in the escalation of issues to Senior Management. Support key stakeholders with developing and maintaining QA procedures, forms, and systems. Support QA system training. Maintain databases and record storage for QA systems. Participate in meetings and communications for QA system information, concerns, and updates. Seeks out information with direction and able support other members of the organization on QA practices. As appropriate, participates in the completion of risk assessment, as related to QA systems. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. General Qualifications - Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) 2-4 years technical experience Previous Quality assurance/engineering experience preferred Solid communication and interpersonal skills Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred Root cause analysis/problem solving training and experience preferred. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 50%, including internationally. Ability to maintain regular and predictable attendance.

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