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Product Regulatory Compliance and Quality Leader

 

Description

Koch Separation Solutions in Wilmington, MA, a suburb north of Boston, is currently hiring for a Product Regulatory Compliance and Quality Leader. In this role, you establish/maintain compliance of KSS spiral, tubular, and batch HF membrane product lines, and ion exchange products with applicable global regulations, including food-contact, drinking water and others. 

What You Will Do In Your Role

  • Apply specialized knowledge to perform various tasks, such as: 
      • Coordinate the exchange of information and communication with the KSS advising law firm to establish the suitable regulatory status of the KSS products under the requirements of applicable agencies
      • Support the Manufacturing group to resolve any GMP matters
      • Lead the preparation for customer audits specifically for pharmaceutical clients, address audit findings related to compliance and fill out customer questionnaires
      • Address customer ad hoc compliance certification requests
      • Verify compliance status for changes, deviations and nonconformance requests for KSS product, component, and manufacturing processes
  • Maintain KSS database of customer agreements for change notifications for KSS products and processes

    The Experience You Will Bring

    Requirements:

    • A working knowledge of food contact regulations

    What Will Put You Ahead

    • Bachelor’s Degree in a scientific field
    • 10 years’ experience establishing food-contact compliance documentation and food contact compliance for US and EU
    • Experience establishing food-contact compliance documentation and food contact compliance for other regions outside of US and EU
    • Experience establishing certifications for drinking water products such as NSF 61/372, UL or Italy ICIM
    • Knowledge of manufacturing products involving plastics and adhesives
    • Experience with membrane filtration 

    This role is not eligible for VISA Sponsorship 

    Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

    At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

    Equal Opportunity Employer, including disability and protected veteran status.
    Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. 
    This employer uses E-Verify.  Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf

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