About the Company: Our client is a rapidly growing healthcare and medical technology organization focused on improving safety, compliance, and operational performance within clinical environments. The company has built a strong reputation by delivering practical, value-driven solutions that help healthcare providers maintain regulatory compliance while improving patient and staff safety. With a collaborative and mission-driven culture, the organization is focused on continuous improvement, operational excellence, and building scalable systems that support long-term growth. The team is composed of individuals who value problem-solving, ownership, and delivering measurable impact for customers.
About the Role: The company is seeking a Quality Engineering Manager to lead efforts focused on shifting quality from reactive inspection and documentation toward proactive defect prevention and process control. The goal is to drive greater operational consistency, reduce defects, and strengthen regulatory compliance outcomes. This role focuses primarily on quality engineering and process improvement, while also serving as a key contributor to the effectiveness of the Quality Management System (QMS) and ensuring regulatory alignment with FDA and ISO standards. This role will play a critical part in improving process reliability, supporting product development initiatives, and positioning quality as a competitive advantage for the organization.
Responsibilities:
- Lead validation and launch activities. Ensuring compliance with FDA general controls and ISO 13485 standards.
- Implement targeted process improvement initiatives (Lean/Six Sigma tools) to reduce process variability and improve first-pass yield.
- Drive reduction of process-related nonconformances and defects through root cause analysis and engineering improvements.
- Support ongoing regulatory compliance, ensuring successful outcomes during internal and external audits.
- Integrate quality practices across operations, engineering, and supply chain functions.
Qualifications:
- 8+ years of experience in medical device quality or manufacturing environments.
- Strong experience with ISO 13485, FDA QSR/cGMP, and medical device regulatory requirements.
- Demonstrated expertise in root cause analysis, CAPA, and continuous improvement methodologies.
- Experience with process validation, equipment qualification, and new product introduction (NPI).
- Ability to collaborate cross-functionally across engineering, manufacturing, and supply chain teams.
Required Skills:
- Strong problem-solving mindset with a focus on systemic root cause resolution.
- Proven ability to drive continuous improvement and operational impact.
- Collaborative leadership style with the ability to influence cross-functional teams.
- Hands-on approach and willingness to engage directly with operational teams.
- High standards for quality and operational excellence.
Pay range and compensation package: [Insert pay range or salary or compensation details here]
Equal Opportunity Statement: [Include a statement on commitment to diversity and inclusivity.]
