Phillips-Medisize is seeking a Quality Manager to support our Costa Mesa, California location! In this role, you will manage, organize and coordinate the activities of the Quality resource area within manufacturing operations. This position is tasked with maximizing company profitability by providing products/services that meet customer expectations and compliance requirements at the lowest cost.
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 in a leadership capacity as the site Management Representative (including facilitating Quality Management Review) to ensure that the facility meets internal policies and requirements, customer requirements, and facility-specific quality systems
- Work with Site Management to establish quality goals and objectives
- Implement quality systems and procedures that provide continuous improvement methodology supporting manufacturing and operational consistency
- Evaluate new and changing country, state, and local regulations that impact relevant operations (i.e. medical device and pharma) and communicate changes throughout the organization to minimize Phillips Medisize's exposure to regulatory risk
- Work with Business Development and Program/Project Management to ensure that regulatory requirements are appropriately considered and accounted for in new programs and projects
- Identify and develop resources required to support customers’ product-specific regulatory affairs needs and requirements
- Ensure compliance with applicable FDA/GMP and ISO quality system requirements
- Ensure appropriate site training (i.e. cGMP practices) is administered
- Interface with manufacturing, engineering, operational excellence, customer service and other functional areas as appropriate to ensure quality systems compliance
- Oversee customer and external regulatory audits
- Coordinate internal quality system audits and track actions needed and taken.
- Actively participate in relevant councils / steering teams to promote consistency and excellence within the discipline across the Corporation
The Experience You Will Bring
- Bachelor’s Degree or Associates Degree
- 3+ years of management experience
- Experience with ISO13485 and FDA QSR
What Will Put You Ahead
- Advanced knowledge of applicable quality system requirements
- Working knowledge of quality tools, such as SPC, design of experiment (DOE), root cause analysis preferred
- Working knowledge of inspection equipment and procedures preferred
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.
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