Operations Quality Engineer

Medical Engineering Consultants LLC.; Brooklyn Park (MN); On-site; USD 50,000 - 100,000; Full time

Job summary

A leading company in medical engineering is looking for an Operations Quality Engineer to support their Quality Management System. This role involves collaborating with product development teams, engaging in quality engineering practices, and ensuring compliance with regulatory requirements. The candidate should be equipped with a B.S. degree in a relevant field and possess knowledge of medical device regulations.

Qualifications

• 1-2+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Ability to organize and prioritize workflow across multiple projects.

Responsibilities

• Function as the operation’s quality representative during engineering projects.
• Participate in NCMR and CAPA investigation and reports.
• Ensure compliance with Quality System Regulations during product development.

Skills

Organizational Skills

Interpersonal Skills

Quality Engineering Concepts

Education

B.S. degree in Science, Engineering or Technology

Job description

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Join to apply for the Operations Quality Engineer role at Medical Engineering Consultants (MEC)

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Job 2276- Operations Quality Engineer-Contract to Permanent or Permanent opportunity in Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Job Summary

Support the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are a plus. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

Key Responsibilities

• Function as the operation’s quality representative during the execution of engineering projects.
• Collaborate with product development teams for changes to existing products are conducted in compliance with the Quality System Regulations.
• Participate in NCMR and CAPA investigation and reports. including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs.
• Participate in cross-functional teams for the review and disposition of nonconforming products or components.
• Participate in cross-functional teams to develop and assist in maintenance of Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).
• Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.
• Participate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols.
• Participate in Design Reviews and FMEA Reviews.
• Participate in complaint investigation. Ensure investigations are thoroughly documented.
• Assist in training of Special Work Orders, Receiving Inspection Processes, and FAIs as required
• Other duties as assigned.
  
  

Qualifications

• Requires a B.S. degree in Science, Engineering or Technology or associated fields.
• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Working knowledge of new product design and development in medical devices.
• Working knowledge of the application of risk management, include PFMEA.
• Excellent organizational and interpersonal skills working in a cross-functional teams.
• Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
• Knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications
• 1-2+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• 1-2+ years’ experience in the medical device industry.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Government Administration

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