About the RoleAs a Senior Quality Engineer, you will lead quality improvement initiatives across product development, manufacturing, supplier quality, and quality systems. You'll work closely with cross-functional teams to solve complex quality challenges, drive corrective actions, and ensure compliance with industry standards and regulatory requirements.
This is an excellent opportunity for a quality professional who enjoys data-driven problem solving, continuous improvement, and making a meaningful impact in a regulated manufacturing environment.
What You'll Do- Partner with cross-functional teams on new product and service development projects, ensuring quality requirements are met throughout the product lifecycle.
- Lead investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
- Develop and implement statistical methods including sampling plans, process capability studies, SPC, trend analysis, and designed experiments.
- Analyze quality data and recommend process and product improvements.
- Drive quality system enhancements and support ongoing compliance initiatives.
- Lead supplier quality audits and corrective action programs.
- Support internal and external audits, including regulatory and certification audits.
- Evaluate and disposition nonconforming materials and processes.
- Develop quality metrics, analyses, and reports to measure system performance.
- Train and mentor employees on quality principles, problem-solving methodologies, and statistical techniques.
- Collaborate with teams across manufacturing, operations, engineering, and supply chain to improve quality performance.
What We're Looking ForRequired Qualifications- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field.
- 6-10 years of combined Quality Engineering, Manufacturing Engineering, and/or Quality Systems experience.
- 6-10 years of experience working within an ISO-certified environment.
- Strong knowledge of quality tools, methodologies, and continuous improvement practices.
- Experience leading root cause investigations and corrective actions.
- Excellent analytical, organizational, and problem-solving skills.
- Strong verbal and written communication skills.
- Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.
Preferred Qualifications- Experience in medical device, healthcare, or other regulated industries.
- Knowledge of FDA Quality System Regulations, GMP, and related regulatory requirements.
- ASQ certification or similar quality certification.
- Experience with statistical analysis software and Visio.
- Prior experience leading or supervising quality personnel.
What Will Make You Successful- A passion for continuous improvement and operational excellence.
- The ability to influence and collaborate across functions.
- Strong data analysis and decision-making skills.
- A proactive approach to identifying and solving quality challenges.
- The ability to manage multiple projects and priorities in a fast-paced environment.
Work Environment- Hybrid manufacturing and office environment.
- Domestic travel up to 25%.
- Occasional international travel as needed.
