Quality/Compliance Engineer

Location: Troy, MI

We are looking for a Quality and Compliance Engineer to monitor and improve our operational processes and outputs. The responsibilities include designing standards, inspecting materials, equipment, processes, and products, developing SOPs within ISO 9001, and determining corrective actions. You will also work with managers and supervisors to implement quality measures.

A successful candidate should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards.

Quality Engineer Responsibilities:

  • Developing and implementing quality standards related to ISO 9001.
  • Monitoring and analyzing quality performance.
  • Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.
  • Collaborating with operations managers to develop and implement controls and improvements.
  • Ensuring that workflows, processes, and products comply with safety regulations.
  • Investigating and troubleshooting product or production issues.
  • Developing corrective actions, solutions, and improvements.
  • Reviewing codes, specifications, and processes.
  • Draft documents for internal and external use.

Compliance Engineer Responsibilities

  • Locate and process external information and documentation.
  • Act as an internal compliance analyst.
  • Collaborate with engineering design teams to resolve prospective design issues.
  • Help develop compliance plans.
  • Provide support with preparation of timetables, cost estimates, and required resources.
  • Assist with determining compliance during testing and on worksites.
  • Recommend product and/or process design changes.
  • Assist with management of compliance databases.
  • Prepare or assist with preparing compliance reports on measurement data and trends.
  • Keep up-to-date on emerging and changing compliance practices and standards.
  • Draft documentation such as user manuals and IQ/OQ/PQs.

Requirements:

  • Degree in quality, industrial, mechanical engineering, or related field.
  • ASQ certification preferred.
  • 2+ years of experience in quality engineering, quality assurance, or a similar role.
  • Strong communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Excellent project management skills.
  • Experience with ISO 9001 or equivalent.
  • Experience with cGMP in a pharmaceutical/dietary supplement/food environment.
  • Strong technical writing skills required.
  • Knowledge of cGMP, CE, ASME, CRN, NFPA, IFC etc. preferred.

Salary commensurate with experience.

To apply for the position, please email your cover letter and resume.

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