Quality Manager

Phillips Medisize; Costa Mesa (CA); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible spending accounts

Health savings accounts

Life insurance

Disability insurance

Retirement plan

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Job summary

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our manufacturing site in Costa Mesa, California.

You will create value by stewarding Quality with your background in medical device quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.You will lead a team, support day-to-day manufacturing operations, manage FDA inspections, drive improvement, and ensure compliance with cGMP

Qualifications

• 5+ years of experience in Quality Assurance within the manufacturing industry.
• 2+ years of experience leading, developing, and managing teams in a manufacturing or regulated environment, including coaching and performance development.
• Experience with quality management tools, technical writing, methodologies (e.g., risk assessment, root cause analysis, FMEA).
• Strong analytical skills with experience in data analysis and trend identification.
• Proven expertise in managing FDA inspections, audits, and developing effective response strategies.

Responsibilities

• Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support.
• Communicate and demonstrate a vision for a culture of quality, through performing at both the strategic and tactical levels.
• Support quality functions of day-to-day manufacturing operations and engineering efforts.
• Provide coaching and development to your team and ensure your entire organization is leveraging its individual and collective comparative advantage.
• Serve as the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, customer requirements, and divisional quality systems.
• Monitor KPIs and drive improvement.
• Ensure compliance with cGMP, and regulatory requirements.
• Act as a communication liaison between the customer and manufacturing facility.
• Participate and drive continual improvement/innovation, corrective action and internal/external customer satisfaction.
• Actively contribute to a safe and inclusive workplace environment.

Skills

Quality Assurance

Team Leadership

Risk Assessment

FMEA

Root Cause Analysis

Data Analytics

FDA Inspections

Education

Bachelor's degree in science

Job description

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Managerto join our manufacturing site in Costa Mesa, California. You will create value by stewarding Quality with your background in medical device quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.

Our Team

Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. We work collaboratively within our Global Quality Organization to deliver compliant and effective solutions to our customers.

What You Will Do

• Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support
• Communicate and demonstrate a vision for a culture of quality, through performing at both the strategic and tactical levels
• Support quality functions of day-to-day manufacturing operations and engineering efforts
• Provide coaching and development to your team and ensure your entire organization is leveraging its individual and collective comparative advantage
• Serve as the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, customer requirements, and divisional quality systems
• Monitor Key Performance Indicators (KPIs) and drive improvement
• Ensure compliance with cGMP, and regulatory requirements
• Act as a communication liaison between the customer and manufacturing facility
• Participate and drive continual improvement/innovation, corrective action and internal/external customer satisfaction
• Actively contribute to a safe and inclusive workplace environment

Who You Are (Basic Qualifications)

• 5+ years of experience in Quality Assurance within the manufacturing industry
• 2+ years of experience leading, developing, and managing teams in a manufacturing or regulated environment, including coaching and performance development
• Experience with quality management tools, technical writing, methodologies (e.g., risk assessment, root cause analysis, FMEA)
• Strong analytical skills with experience in data analysis and trend identification
• Proven expertise in managing FDA inspections, audits, and developing effective response strategies

What Will Put You Ahead

• Bachelor's degree or higher in a scientific discipline
• Proven experience in GxP audits, quality management systems, and CAPAs
• Competency in statistical tools and process validation
• Effective cross-functional collaborator with teams such as Operations, Engineering, Regulatory Affairs

For this role, we anticipate paying $100,000 - $135,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

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.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here .

Who We Are

At Koch, employees are empowered to do what they do best to make life better. Learn how ourbusiness philosophy helps employees unleash their potential while creating value for themselves and the company.

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.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information. (For Illinois E-Verify information clickhere , aquí , or tu ).