Mercy Health

  • Manager-CPS Quality Production

    Requisition ID
    Position Type
    Full Time
    Quality Assurance Regulation
  • Overview

    Job Template Header


    We’re a Little Different


    Our mission is clear. We bring to life a healing ministry through our compassionate care and exceptional service.  


    We don’t believe in jobs at Mercy, we believe in careers that match the unique gifts of unique individuals; careers that not only make the most of your skills and talents, but also your heart.


    At Mercy, you’ll feel our supportive community every step of your day, especially the tough ones. We’re a team and love working that way. That team is expanding, and we currently have exceptional opportunities to help our communities grow.


    Responsibilities and Qualifications



    Responsibilities include the complete supervision of day to day Quality Assurance processes that take place in the custom surgical pack manufacturing operation (CPS).

    The Manager-CPS Quality Production will train and provide guidance and supervision to other Quality Assurance team members on both the first and second shifts.

    Continual review of the Custom Pack Solutions (CPS) division (as it relates to Quality and Regulatory objectives) is required to ensure that the department is in compliance with all applicable regulations at all times.

    Collaboration with other department leaders and managers is essential to ensuring that production and quality work together to meet company-wide goals.

    Other responsibilities include compilation of quality and production data from multiple sources and compiling the information for routine reporting and evaluation using statistical techniques. Management of Quality Concerns, customer complaints, and the ETO sterilization program is required.


    1. Responsible for the supervision and guidance of Quality Assurance process as it relates to the Custom Procedure Solution (CPS) department. Main work functions to take place during the day shift; however, availability to e-mail and phone inquiries may be required to up 11pm Monday-Friday.


    2. Responsible for assisting with compliant handling relating to outgoing complaints (to suppliers) as well as complaint handling from ROi/CPS customers. Must investigate and resolve complaints including the implementation of corrective and preventive actions in Quality System Management tool.


    3. Responsible for gathering data from multiple sources in order to create and maintain quality reports including complaint management, internal defect review, sterilization data, sigma scoring, supplier performance. Should continually seek out other types of quality data which may improve quality, performance, and moral.


    4. Responsible for performing continual informal reviews within the manufacturing environment to ensure a constant state of preparedness in the event of a FDA audit.


    5. Lead the Quality Review Board meetings with Production staff. Participates in CAPA's.


    6. Responsible for supervising routine review and release of product processed in the Ethylene Oxide Sterilization process.


    7. Responsible for investigating sterilization batches which deviated/failed to achieve desired parameters.


    8. Responsible for participating in the annual validation exercise in order to maintain compliance to applicable regulation.


    9. Responsible for adequate document control for CPS.


    10. Responsible for assisting in the hiring process for new Quality Assurance Technicians, development of training and continuing education activities, scheduling, staff evaluations, team building and effective personal growth of direct reports.


    11. Performs other duties as assigned.




    Because you’re committed to excellence, you understand the importance of being properly prepared for your role at Mercy. That’s why you’ll bring to your role the right set of qualifications:


    • Bachelor's degree (preferably science) from an accredited College institution
    • Minimum of three years of experience in a Medical Device Production or Quality Assurance setting


    We’ll Support You at Work and Home


    Our foundations are built on dignity and respect. Modern Healthcare Magazine named us as a “top 100 places to work.” We go out of our way to help people feel welcomed. We offer day-one comprehensive health, vision and dental coverage, PTO, and employer-matched retirement funds, even to part-time employees. We’re proud to provide tuition reimbursement to help you grow and learn new skills.


    What Makes a Good Match for Mercy


    Compassion and professionalism go hand-in-hand with us, along with exceptional quality care. Having a positive outlook and a strong sense of advocacy is in perfect step with our mission and vision. We’re also collaborative and are not afraid to do a little extra to deliver excellent care – that’s just part of our commitment. If that sounds like a fit for you as well, we encourage you to apply.

    courage you to apply.

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