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    Quality Engineer II - Minneapolis, United States - Vital Path

    Vital Path
    Vital Path Minneapolis, United States

    Found in: Lensa US 4 C2 - 5 days ago

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    Description


    Join VitalPath in New Hope as a Quality Engineer IIAbout VitalPathVitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function.

    We're excited about this important work and bring vital energy to our customer partnerships.

    In our growing organization it's important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits.

    If you want to make a difference in people's lives and be a part of a friendly, fun place to work with people that value diversity, come join our teamAbout the PositionThis person is primarily responsible for providing technical support to ensure Customer requirements are understood and properly implemented.

    The Quality Engineer II will work cross-functionally contributing to Development and Manufacturing, Engineering, Qualification, and Validation activities.

    Supports Engineering, Operations, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.

    ResponsibilitiesSupport engineering, manufacturing, inspection, qualification, and validation of productsDevelop and implement quality improvement with working knowledge of Quality standards and systemsAssures compliance of the Quality Management Systems (QMS), ISO 13485:2016, and customer/regulatory requirementsSupport Development activities for the transition of Manufacturing Processes and related controlled documentation from prototype control to pre-production control to commercial production controlWorks with customers and suppliers to resolve quality related issuesSupport and participate in 3rd party and customer audits, as neededWork cross-functionally on failure investigations, root-cause analysis, and corrective action implementationDevelop, approve, review, and update controlled documents such as procedures, manufacturing procedures, work instructions, forms, etc.

    Train personnel, as needed, on new or updated QMS documentsReview and approve customer and internal drawings and specificationsEnsure that records are established, accurate and maintained per QMD requirementsDevelop and implement systems for Quality and Inspection supportSupport implementation of overall company systems that related to QualityOther duties as assignedRequirementsBachelor's Degree in engineering or related discipline3 years of Quality Engineering experience in catheter medical device manufacturing3 years of experience in support of QMS auditsExperience working in quality systems defined in 21 CFR 820 and ISO 13485Demonstrated ability to implement, execute, and maintain quality system policies and proceduresAbility to define problems, collect data, establish facts, and draw valid conclusionsDiverse knowledge of inspection and control methods, techniques, and documentationAbility to interpret and understand drawing specifications, tolerances, procedures for inspection, and the application of sampling plansAble to sit/stand at a desk for extended periods of timePreferred Skills & Experience2 years' experience working with automated inspection systemsDemonstrated experience in software validationExperience in product development and process design development team environmentBenefitsComprehensive, Low Cost Health and Dental Insurance Plans AvailableVision InsuranceHealth Savings Account with company contributionShort and Long Term DisabilitySupplemental insurances (short term disability, AD&D, life insurance, and more)Paid Time OffPaid Holidays401K with company matchCompetitive compensationOpportunities for career growth and advancementVitalPath is an Equal Opportunity Employer.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information.

    VitalPath participates in E-Verify.
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