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Quality Assurance Engineer II

  • Permanent
  • Anywhere

Website Mindlance

Mindlance

Company : Mindlance

Country: United States

Location : Noblesville, Indiana

Post: Sat, 24 Sep 2022 03:36:43 GMT

Expires: Sat, 22 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

SK (XXJP(phone number removed))

Quality Assurance Engineer II

Is this a temp to perm position – no

A brief overview of your facility and what you produce – we produce Healthcare Ultrasound Medical Devices. We also remanufacture, distribute and repair them

Screen- Onsite, Phone, or via Teams ? Screen via Teams

Contract Quality Engineer Requirements

Degree in Engineering, preferably Industrial and Mechanical Engineering.

5 years previous experience in Quality Engineering for Medical Device Company.

Job Description Summary

Work with engineering and business team to resolve product issues and implement standard work.

CAPA Leader.

Review and approval of equipment qualifications, process validation, and production documents.

Mana implementation of product holds, concessions and deviations.

Metrics & data analysis

Description

The Quality Assurance Engineer III is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. Key responsibilities include: Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gau R&R, etc. Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Develops risk manament tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Manament process. Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manar.

Qualifications: 1. Bachelors degree 2. 5 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. 3. Demonstrated understanding of product development lifecycles, design chan and document chan control, process verification and validation methodologies, 6. Demonstrated experience using word processing, spreadsheet, and presentation software. 7. Demonstrated understanding of continuous quality / process improvement tools:

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