Quality Engineer/Regulatory Specialist


Job Title:
 Quality Engineer / Regulatory Specialist

Job Description: Probo Medical’s growth plans are very ambitious as we have built a successful working business model positioned for substantial growth.  From Probo Medical’s foundational core values to a clear vision of employee traits, skillsets, and accountability we are looking for the right people who we can position for success and become a key contributor in helping us to achieve our goals.

Probo Medical is hiring a Quality Specialist; the primary responsibility of this role is to support and improve Probo’s Quality System and Metrics.  This is a high profile position that will interact with all levels within the organization and report directly to the COO.

Our goal is to build a world class operations department centered on a probe refurbishing core competency.  If you are interested in being part of a high growth company that will make a difference in people lives, have a passion for efficiency, likes solving problems, and strive for excellence this role may be for you.

Job Duties:

  • Maintain and improve Probo’s current Quality Manual and supporting Quality Procedures.
    • Create, implement and maintain relevant Quality Procedures
    • Position will have personal responsibility for CAPA, Internal Auditing, and Reporting quality procedures in addition to any other procedures needed.
  • Develop plans to prepare Probo for ISO 13485 Certification and any potential regulatory needs. Work with management to execute plan.
  • Implement, record and report internal and external quality metrics, including internal re-works and warranty claims.
  • Participate in customer visits and all audits. Prepare for the visits and facilitate the best possible outcomes.
  • Lead efforts to ensure Probo’s inventory and ERP system is accurate and supports a quality operation. This will include working with Management and external consultants to implement changes and improvement to the system.

Skills, Qualifications and Experience:

  • Bachelor’s Degree in Engineering or Quality related area
  • 2+ years experience in a similar role (Life Sciences or other regulated industry preferred).
  • Proven, successful experience with Quality Systems
  • Strong organizational skills and good time management
  • Strong communication skills, both written and verbal
  • Strong analytical approach to metrics and / or quality management
  • Good attention to detail
  • Self-starter able to work independently without much oversight.
  • Ability to read, write and speak English.
  • Fluent computer data entry skills. Outlook, Salesforce, Google Drive, etc.
  • Lean and/or Six Sigma training preferred

Disclaimer:  This job description is not meant to be an all-inclusive statement of every duty and responsibility of the jobholder.  Certain features of this job are described in the above headings, but are not necessarily limited to the above written statements.  They may be subject to review.  All positions within Probo Medical may include other duties as assigned.  Probo Medical is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, creed, age, national origin, sex, sexual preference or handicap.