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Openings >> Quality Engineer
Quality Engineer
Summary
Title:Quality Engineer
ID:1159
Department:Quality
Location:Sandpoint, ID
Description
Biomedical Innovations, a Nissha company, is currently seeking a Quality Engineer to join our team in Sandpoint, Idaho. This position is responsible for overseeing quality protocols for product manufacturing processes and equipment, including validations and process improvements.

Essential Responsibilities Include:
  • Develop, coordinate, execute, and oversee IQ, OQ and PQ protocols for products, processes and equipment with cross functional teams.
  • Write reports summarizing results and statistics for all equipment, product or process validation projects.
  • Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
  • Aid in determining User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes.
  • Participate as an active member in the new products development team. Collaborateswith engineering team on FMEA’s.
  • Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
  • Develop, plan, design, implement, and support manufacturing processes, tooling and procedures for the production of medical devices.
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
  • Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.
  • Assist Engineering with DOEs to demonstrate interactions of variables.
  • Provide day-to-day support to engineering and manufacturing for design control planning and design transfer activities.
  • Provide input and assists in change control assessment for validated systems.
  • Develop and revise as necessary FDA/ISO documentation supporting equipment and process validations including SOPs, EOPs.
  • Has knowledge of commonly-used concepts, practices, and procedures within a medical device field.
  • Manage CAPA and Complaint Responses for assigned customers.

Minimum Qualifications:

  • BS Degree in Engineering, Science, or technology field preferred. Other educational experience may be considered when coupled with extensive Quality Assurance working experience.
  • Minimum 5 years’ experience in manufacturing / quality engineering required.
  • CQE, CQA or initiative to complete certifications desirable.
  • Experience in the medical device industry development and deployment of Quality System, process controls, and continuous improvement methods desired.
  • Experienced with Six Sigma methodologies.
  • Knowledge and working application of FDA cGMP; ISO, ANSI/ISO/ASQC; CMDAS requirements.
  • Working knowledge of 510k, and CE Technical file submissions.
  • Knowledge and working application of Validation Principles and guidelines and industry practice.
  • Knowledge and working application of FMEA and Risk Analysis.
  • Practical experience in product design and development.
  • Knowledge and working application of standard operating procedures.
  • Demonstrated strong analytical problem solving (CAPA), teaming and communications/interpersonal relationships.
  • Primary/Secondary party compliance auditing experience.
  • Computer competency in Microsoft Word, Excel, Outlook, Access and other databases, and Power Point.
  • Strong reading and comprehension skills; ability to read specifications, engineering drawings and documents.
Biomedical Innovations offers great benefits including medical and dental, 401k, life insurance, PTO, paid holidays and more!

 

Biomedical Innovations, a Nissha company, is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call Biomedical Innovations at (208) 263-5071.

This opening is closed and is no longer accepting applications
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Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
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Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

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