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Quality Manager

Description

Phillips-Medisize, a Molex Company is seeking an experienced Quality Manager at our Little Rock facility to partner with site leaders in the goal of maximizing company profitability by providing products and services that meet customer expectations.

This role will manage, organize and coordinate the activities of the Quality Team, devise and implement quality systems/procedures that provide continuous improvement methodology supporting manufacturing and support groups to ensure customer satisfaction is maintained. 

What You Will Do In Your Role

  • Provide direction and leadership to the Quality department including managing performance, career development, fostering open communication in all directions, ensuring alignment with and accomplishment of goals/objectives, applicable administrative processing and fostering a team environment
  • Serve as the Management Representative with primary responsibility to facilitate the management review activity and ensure that the facility meets internal policies and requirements, customer requirements and facility specific quality systems
  • Identify and develop resources required to support customers’ product-specific regulatory affairs, needs and requirements
  • Develop procedures and provide in-house training to cGMP practices and QSR’s
  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Communicate and coordinate activities including internal and external approvals of validation
  • Coordinate new process techniques that improve overall job efficiencies
  • Implement system and procedures that assure compliance with quality standards
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Facilitate communications between engineering, manufacturing and quality functions
  • Communication liaison between the customer and manufacturing facility
  • Ensure compliance with FDA/GMP and ISO quality system requirements
  • Work with leadership to establish quality goals and objectives

The Experience You Will Bring

Requirements:

  • Minimum 5 years directly related experience
  • 2+ years in a leadership role
  • Knowledge of FDA and International regulations and ISO standards related to medical device design and manufacturing (e.g. MDR, 21 CFR 11, 820, 211 and ISO 13485, 14971)


What Will Put You Ahead

  • Knowledge of current good manufacturing practices (cGMP)
  • Knowledge of quality tools, such as SPC, design of experiment (DOE) and root cause analysis
  • Bachelor’s or Associates Degree in Quality, Business, Engineering or similar






    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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