Sr. Quality Engineer

1 week ago

Saint Paul, United States SMS Staffing Inc. Full time
Job DescriptionJob DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Sr. Quality Engineer Job Title: Sr. Quality EngineerJob Location: St. Paul, MN, U.S.A. 55117Job Type: Contract (possible extension or convert to hire)Pay: Starts at $42.00 an hourShift Structure: ONSITE, 8:00 AM - 5:00 PM, Monday to Friday, 40 hours per weekThe role of the Sr. Quality Engineer:
  • Lead on-time completion of Quality Assurance (QA) engineering deliverables.
  • Oversee and make decisions related to quality systems, including CAPA (Corrective and Preventive Action) systems.
  • Work with key stakeholders to develop and maintain QA procedures, forms, and systems.
  • Develop and lead training programs for QA systems, influencing and guiding team members in product review and analysis.
  • Maintain databases and record storage for QA systems, ensuring timely processing of QA requests.
  • Lead meetings and communications for QA system information, concerns, and updates.
  • Mentor and lead others in QA data analysis, trending, and reporting.
  • Proactively identify and address manufacturing-related concerns in alignment with organizational goals.
  • Lead the Global CAPA team, providing training, oversight, and deliverables.
  • Serve as the lead representative for presenting QA System to internal and external auditors.
  • Investigate and resolve system non-conformances and concerns identified during audits.
  • Contribute to risk assessments related to QA systems.
  • Support Company initiatives aligned with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
About the Sr. Quality Engineer: The ideal candidate will have the following skills and experience:
  • Bachelor's degree in Engineering, Technical Field, or equivalent (advanced degree preferred).
  • 5+ years of technical experience in Quality Assurance/Engineering.
  • Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, and ISO 13485.
  • Solid communication and interpersonal skills.
  • Demonstrated project management and leadership skills.
  • Adept at preparing clear and concise technical documentation, including quality procedures, work instructions, test protocols, and reports
  • Must have hands-on experience in manufacturing process monitoring.
  • Experience with line decommissioning is a specific requirement for this role.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Prior medical device experience preferred.
  • ASQ CQT, CQE, CQA certification preferred.
  • Six Sigma root cause analysis/problem-solving training and experience preferred.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes, and meets deadlines in a timely manner with strong organizational and follow-up skills, as well as attention to detail.
Benefits: At our client company, you can have a good job that can grow into a great career.
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities.
Come join the SMS team It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right.

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