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Quality System Manager

4 months ago

St Paul, United States Staff Works Full time

ROLE RESPONSIBILITIES:

  • Onboard and administer our clients electronic quality management system and support cross functional teams with CAPA, MOC, and Non-Conformance management, including initiation, follow-up and closing out items on time.
  • Support cross functional teams with the investigation of product inquiries and internal quality issues to identify the root causes and recommend/implement corrective and preventative measures to eliminate recurring quality issues.
  • Prepare, deliver, and participate in training initiatives.
  • Review documentation, SOPs, reports, and records for internal and external compliance to standards. Ensure SOPs, reports, and records are created, controlled, and reviewed/revised, as required.
  • Support the Supplier Quality management program by establishing and maintaining quality requirements, evaluating supplier performance, and participating in supplier audits and reviews, as required.
  • Establish a Management Review program and prepare for and facilitate required management review meetings.
  • Establish an Equipment Calibration and Maintenance program that includes scheduling, tracking of status, and carrying out repairs or replacements as required. Review and provide input on equipment and process validations ensuring all measuring and testing equipment used in the manufacturing and QC process are calibrated and maintained.
  • Establish an audit program and conduct internal audits to ensure compliance with the quality management system, internal and external regulations, and customer requirements. Facilitate and coordinate external audits for certification, ensuring alignment with applicable standards.
  • Support functional teams with identifying, analyzing, and mitigating risks in line with enterprise risk management best practices. Maintain a risk register and provide regular updates and reports on the risk profile.
  • Enable a culture of continuous improvement by supporting lean initiatives and process improvement projects, with an emphasis on increasing efficiency and reducing timelines and cost.
  • Provide reports with the appropriate level of detail and frequency to the Head of Quality Assurance and leadership showing the overall performance, use, and health of our QMS as well as any trends in quality or defects with the goal of mitigating and preventing recurrence and future problems.

REQUIREMENTS:

  • Bachelors degree in agriculture, plant science, quality, or related field.
  • 10+ years experience in agriculture supply chain, seed production, breeding, plant science or related field and 5+ years experience in a quality assurance role.
  • Hands on experience with implementing and managing quality management systems, specifically ISO9001. Working knowledge of ZenQMS is an asset.
  • Experience in tracking and mitigating operational and corporate risks.
  • Ability to read, write, and understand product specifications, SOPs, work instructions, and customer, regulatory, and legal requirements.
  • Exceptional leadership, communication, and interpersonal skills
  • Strong organizational skills with good attention to detail
  • Strong analytical and problem-solving skills to creatively assess processes, gaps and develop recommendations.
  • Proficient in SharePoint, Teams, Visio, and the MS Office suite of tools, specifically Excel, Word, and Outlook. Working knowledge of Power BI is a definite asset.