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 Menomonie, Wisconsin Campus is seeking a Sustaining Quality Manager to support manufacturing of injection molded parts and medical device assembly.
This role will manage, organize and coordinate the activities of the quality resource area with the goal of maximizing company profitability by providing products/services that meet customer expectations. Devise and implement quality systems/procedures that provide continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.
What You Will Do In Your Role
- Provide direction and leadership to the Quality department including; people management as follows: personnel management, managing performance, team career development, fostering open communication in all directions, ensuring team is aligned with and accomplishing goals/objectives, applicable administrative processing, and fostering a team environment
- Serve as, or lead, the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, customer requirements, and facility specific quality systems
- Devise and implement quality systems/procedures that provide continuous improvement methodology supporting manufacturing and operational consistency
- Ensure compliance with FDA/GMP and ISO quality system requirements
- Facilitate management review activity
- Identify and develop resources required to support customers’ product-specific regulatory affairs needs and requirement
- Work with management to establish quality goals and objectives
- Develop procedures and provide in-house training to cGMP practices and QSR’s
The Experience You Will Bring
- Bachelor’s or Associates Degree in quality, business, or engineering
- 5+ years in a leadership role and relevant work experience
- 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 practice (cGMP)
- Knowledge of quality tools, such as SPC, design of experiment (DOE), root cause analysis
Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
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