NPI Quality Manager
Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. Our Maumelle, Arkansas location is seeking a NPI Quality Manager to support manufacturing of injection molded parts and assembly.
What You Will Do In Your Role
- The NPI (New Product Introduction) Quality Manager provides direction and leadership to the NPI Quality group including people management as follows: managing performance; addressing disciplinary issues; hiring; assisting people with career development; communicating information to direct reports, passing information up the management chain and fostering open communication; ensuring team is aligned with and accomplishing goals/objectives; administrative processing; and, maintaining trust and confidentiality while fostering a team environment
- Support management review activity
- Work with Sales and Marketing, Program and Project Management to ensure that regulatory requirements are appropriately considered and accounted for in new programs and projects
- Support the AQP (Advanced Quality Planning) process which focuses on receiving requests for new customer quotes, understanding, and implementing appropriate regulatory requirements, verification, and validation, and ensuring a success transfer to the Sustaining Quality Team.
- Provide technical support and coordinate quality related issues on new and existing projects
- Negotiate, review, and approve quality agreements, validation requirements, and product accept/reject criteria and inspection methodologies for strategic customer programs.
- Provide guidance and leadership support to PM Site Quality teams on strategic customer product quality issues and solution recommendations.
Skills, Abilities, and Expectations:
- Demonstrated superior communication, teamwork and organizational skills
- Ability to develop and meet project/program schedules, along with contingency plans
- Demonstrated ability to identify and develop future quality strategic improvements
- Demonstrated ability to think out of the box, recommend options and implement systems
- Leadership skills including ability to maintain confidentiality
- Some travel required for customer engagements and site-to-site involvement
The Experience You Will Bring
- Minimum of 5 years of related experience
- Project/Quality Engineering experience
- Quality Management Systems experience including ISO13485
What Will Put You Ahead
- Prior supervisory experience
- Technical injection molding & tooling experience
- Product design and development experience along with new product introduction
- Experience with FDA 820 and 210/211
- B.S. degree in engineering or technical field
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