Combo Products Facility with full relocation to Texas. High volume facility with Sterilization on site. Position open due to growth and promotion. Apply today!
The Staff Regulatory Compliance Engineer will:
- Execute internal audits according to the established internal audit procedures. Ensure internal audit results are reported to management having responsibility for the matters audited.
- Support/lead external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back-room arrangements, identifying/preparing SME’ s, etc. Support management of external audits/inspections of the site.
- Provide guidance to ensure timely and adequate responses to internal and external audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
- Assure that internal and external audit metrics are accurately captured and published. Create reports and communicate performance against metrics to key stakeholders. Highlight/communicate adverse trends in metrics and take risk-based action to remediate.
- Support/lead implementation of new/revised regulations and standards for the site.
- Apply comprehensive and diverse knowledge of quality systems in work assignments, projects and initiatives.
- Support/lead projects to ensure compliance with quality system and regulatory requirements.
- Act as emerging authority in the regulatory compliance field.
- Connect and collaborate with the regulatory compliance teams of other sites, regions, and business groups to attain common objectives.
- A minimum of a Bachelor’ s degree in a technical field.
- A minimum of 5 years of experience in a Quality, Manufacturing, or Engineering function in a regulated industry
- Project management or leadership experience with Quality Systems or Regulatory initiatives
- Good written and oral communication skills as well as report writing, presentation and training skills
- Accomplish objectives in a timely manner with limited or without day-to-day supervision.
- Good interpersonal skills; customer oriented.
- Computer Literate. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Experience working in the medical device or pharmaceutical industries
- Auditing experience
- Knowledge of medical device or pharmaceutical regulations and standards.
- Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification
- Training in Process Excellence/Six Sigma tools and methodologies or Certification
- Experience with Microsoft Project or Minitab
- Experience in leading and managing projects
Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.