Quality Engineer
About the role
A contribution-motivated Quality Engineer is sought to join Phillips Medisize, a Molex Company, in New Richmond, Wisconsin. The ideal candidate will leverage their background in Medical Device Quality Assurance, a passion for quality and compliance, and a commitment to excellence to lead quality assurance activities for new product introductions.
Responsibilities
- Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc.)
- Develop and maintain quality plans for new medical device product introductions
- Perform audits and inspections of NPI processes to ensure adherence to internal and external quality standards
- Manage and oversee quality documentation, including specifications, validation reports, and product dossiers
- Support regulatory submissions by compiling and reviewing quality-related documentation
- Monitor product performance during initial production runs to identify opportunities for improvement
- Facilitate training and knowledge sharing across teams regarding quality expectations and best practices
- Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness
- Lead risk management activities including Design FMEA, Process FMEA, and Control Plans
- Collaborate with suppliers on quality requirements and audits to ensure component and material quality
- Facilitate root cause investigations and corrective actions for quality issues during product launch
- Conduct quality reviews and ensure alignment with internal standards and external regulatory bodies
- Assist with documentation and audit readiness for FDA inspections and ISO 13485 certification
- Drive continuous improvement efforts to enhance product quality and manufacturing processes
Requirements
- Bachelor’s degree in engineering, Quality, Life Sciences, or related field
- Experience with FDA QSR, ISO 13485, and medical device regulatory environment
- Strong knowledge of quality tools such as SPC, FMEA, 8D, CAPA
- Excellent problem-solving skills and ability to work cross-functionally
- Experience with product validation, verification, and risk management in medical devices
- Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship
Qualifications
- Passionate about ensuring the highest standards in product quality and compliance
- Committed to excellence and continuous improvement
- Ability to work collaboratively within a team
- Knowledgeable in regulatory environments and quality assurance practices
Skills
- Quality assurance and compliance expertise
- Project management and leadership skills
- Problem-solving and analytical skills
- Effective communication and interpersonal skills
- Knowledge of medical device regulations and standards
Benefits
At Phillips Medisize, we offer a comprehensive benefits package designed to support your overall wellbeing. This 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.