Quality Engineer (Hybrid)
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. We are currently seeking a Quality Engineer to support the development, validation and manufacturing of injection molded parts and assembly.
What You Will Do In Your Role
- Lead AQP process, develop product quality criteria and execute associated deliverables during new product introduction.
- Establish Bill of Materials and control prints, drawings and product specifications.
- Establish Supplier Controls and Purchase Part Approval Process deliverables.
- Establish validated test methods, molds, and assembly equipment.
- Establish drug and serialization deliverables.
- Establish quality system deliverables inclusive of quality events, deviations, MRBs corrections, CAPAs, Batch Records, and Certificates of Compliance.
- Initiate and manage customer/internal corrective actions using data based, structured, problem solving methodology.
- Acknowledgment and understanding of all customer General Quality Agreements, General Quality Requirements and standards, as set by each customer
- Responsible for being a communication liaison between the customer and manufacturing facility
- Implement systems and procedures that assure compliance with Quality Standards
- Development and implementation of statistical incoming and in-process sampling/control plans
The Experience You Will Bring
- Bachelor’s degree in an Engineering related field OR 4 + years of direct Quality Engineer experience
- Minimum 2 years quality/regulatory experience
What Will Put You Ahead
- Understanding of the project development process, associated terminology, and quality system requirements
- Ability to effectively present information and respond to questions from group of managers, sales, and customers
- Ability to identify problems, and develop and implement actions to resolve them
- Ability to motivate and influence people to achieve customer satisfaction
- Experience in the medical and/or pharmaceutical manufacturing industry
- Experience analyzing statistical data
- Experience working with SAP
Hybrid work is a flexible working model where employees work partly in the physical workplace, and partly remotely – at home or from another workspace.
In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.
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