Dohmen Life Science Services

  • Quality Engineer - Regulatory and Compliance

    Job Locations US-MO-Chesterfield
    Job ID
    2018-2029
    # 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 design and implement quality-related projects and assist in operational, managerial and engineering activities to ensure that the quality of services to patients and clients are achieved, maintained and improved.  This includes new product launches, and ensuring change control and business/therapy continuity requirements are met.  This position helps to ensure compliance to the Quality Management System and regulatory/accreditation requirements, and improvement in business processes and services.

     

    Critical Responsibilities:

    • Support senior management in the compliance to the Quality Management System (QMS), including temperature monitoring and validations, and new/modified facility and equipment qualifications
    • Provide quality engineering tools, methods and training to the appropriate staff
    • Evaluate existing procedures (SOP, RD, WI) and quality practices, and when necessary, make recommendations for improvement to senior management to documentation and records 

    Essential Duties and Responsibilites:

    • Administer the Intelex quality nonconformance (QNCR) reporting and corrective/preventive action (CAPA) system, which includes client and patient complaint/grievance management
    • Represent the Quality Assurance team in new program and product launches by actively participating on launch teams
    • Working with functional areas to ensure that change control requirements are met and documentation is completed and approved, which may include Operation, Installation and Performance Qualifications (OQ, IQ, PQ) as needed
    • Perform engineering studies on new equipment to ensure that new equipment meets DLSS expectations
    • Be the back-up to the Director, Quality Assurance for the approval and verification of QNCR/ CAPA documents
    • Develop and implement the supplier management process for the site and work with the Audit Specialist to execute the supplier auditing and qualification process
    • Ensure site meets internal and industry requirements for product security and release, including requirements if the site distributes controlled substances
    • Be the Information Retention Policy (IRP) Coordinator for the site, which includes ownership of the site IRP and working with the QA Process Analyst in the execution of the policy
    • Establish, follow and improve corporate and site procedures and associated instructions and resource documents
    • Be the quality representative for Business and Therapy Continuity Plan activities, and ensure that period testing of each plan is performed in accordance with procedure
    • Provide new team member training on the Intelex QNCR and CAPA system
    • Other assignments and projects as needed
    • 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 or business administration
    • 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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