Dohmen Life Science Services

  • Quality Engineer - Regulatory and Accreditation

    Job Locations US-MO-Chesterfield
    Job ID
    2018-2035
    # of Openings
    1
    Category
    Quality Management Systems
  • Overview

    Our Culture:

    At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.  Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:

     

    Caring: We are empathetic and respectful.  We ask “How can I help you?”

    Committed: We are dedicated and persistent.  We ask “How can I make it happen?”

    Creative: We are inventive and imaginative. We ask “How can I do it better?”

    Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”

    Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”

     

    The Position:

    The purpose of this position is to ensure that the site is successful in client audits, accreditation surveys (including, but not limited to VAWD, ACHC and URAC), and regulatory inspections.  This role will collaborate with all teams to prepare for audits, surveys and inspections, and respond to any observations with plans of correction.  This role will monitor report and facilitate changes due to any changes in accreditation standards and work with the Pharmacist-in-Charge regarding any regulatory changes.  This position will also assess and educate the site relative to privacy and HIPAA requirements. 

     

    Critical Responsibilities:

    • Lead the site effort in achieving and maintaining third-party accreditation programs, such as URAC, ACHC and VAWD, which may include the validation and reporting of annual measures utilizing a 3rd party validator as required by the accrediting body
    • Communicate with and educate site team members to ensure compliance to privacy and HIPAA requirements
    • Lead any new accreditation efforts and manage changes to current accreditation standards, which includes the determination, reporting and resolution of any gaps identified
    • Evaluate existing procedures and quality practices, and when necessary, make recommendations for improvement to senior management and client designates for documentation changes

     Essential Duties and Responsibilites:

    • Lead site survey and inspection readiness efforts (VAWD, URAC, ACHC, Board of Pharmacy, client audits, etc.)
    • Monitor and report changes in accreditation standards to senior management, which includes determining and communicating the impact to the quality management system (QMS)
    • Collaborate with site teams annually to acquire data needed for URAC reporting measures, working the 3rd party validator and submit measures
    • Ensure the Plans of Correction to audit results are developed, formalized and submitted as required
    • Provide, and if necessary validate, reporting measures required by current or new accrediting bodies
    • Partner with the Pharmacist in Charge to monitor and report regulatory changes that impact the site
    • Verify licensure compliance for the site, facility and staff, and back up the Licensing Coordinator as needed.
    • Partner with the Privacy Team in Denver to understand requirements relative to patient privacy and HIPAA requirements, and be the privacy resource for the St. Louis site
    • Assist the Audit Specialist in the development of checklists for and execution of internal audits for privacy and HIPAA
    • Perform PHI risk assessments and assist in the resolution of QNCRs for PHI incidents
    • Establish, follow and improve corporate and site procedures and associated instructions and resource documents
    • Provide new team member training on the quality management system and accreditations
    • Other duties as assigned.
    • Occasional travel may be required (less than 20%).

    The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

     

    An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

     

    Minimum Qualifications:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

     

    • Bachelor’s degree in engineering, mathematics/statistics or technical science
    • Two (2) years prior work experience in a quality, healthcare or life sciences role
    • Industry certification required (ASQ Certified Quality Engineer (CQE), Technician (CQT) or Process Analyst (CQPA), Six-Sigma Belt, etc.)
    • Proficient in the use of MS Office programs, specifically Excel, Word and PowerPoint
    • Excellent verbal, written, and consultative communication skills
    • Ability to manage multiple priorities and meet organizational goals
    • Ability to work with staff at all levels of the organization 

    Preferred Qualifications: 

    • Advanced degree in engineering, business administration, or equivalent
    • Advanced in the use of MS Excel and PowerPoint, proficient in the use of Visio, and statistical software applications (examples: Intelex, Minitab, Infinity QS, etc.)

     

    Physical and Mental Demands:

    This is a largely sedentary role.  While performing the duties of this job, the employee is regularly required to talk, hear, type and engage in repetitive motion. 

     

    The employee frequently is required to walk; use hands to finger, handle or feel; and reach with hands and arms.  The employee is occasionally required to stand or grasp. The employee is intermittently required to stoop or crouch; push or pull; or kneel. 

     

    The employee must occasionally lift and/or move up to 10 pounds and intermittently lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

     

    This role requires mental alertness. The employee must regularly communicate both verbally and written; concentrate on tasks; and remember and observe details. The employee must frequently adjust to changes; handle stress and emotions; and think analytically.

     

    The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

     

    Working Environment:

    This job operates in a professional office environment. This role routinely uses standard office equipment. The noise level in the work environment is usually moderate.  The employee is not substantially exposed to environmental conditions.

     

    The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

     

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