Description:
Here, your voice matters. You’ll be part of a team that values your expertise and encourages you to bring your full self to work. This company offers more than just a job—it offers a purpose. You’ll be supported by inspirational leaders and like-minded peers, all within a collaborative, inclusive, and growth-oriented culture.
Expect a Total Rewards package that includes competitive salary and benefits, ongoing professional development, career progression opportunities, and a strong focus on work-life balance.
What You’ll Be Doing
- Lead & Manage: Oversee a team of 5–7 Quality Engineers, providing guidance, support, and performance development.
- Regulatory Excellence: Ensure adherence to ISO 9001/13485 standards and regulatory requirements in the medical device sector.
- Cross-Functional Collaboration: Work with manufacturing, R&D, and external partners to ensure quality during new product launches.
- Process Validation: Manage and support validation activities for new equipment, processes, sterilization, and cleanroom operations.
- CAPA & GMP Oversight: Ensure compliance with Corrective and Preventive Actions (CAPA) and Good Manufacturing Practice (GMP) standards.
- Drive Improvement: Champion continuous improvement initiatives, including Six Sigma and SPC (Statistical Process Control).
- Customer Engagement: Interface with external customers to align quality outcomes with expectations.
- Documentation: Maintain and prepare quality documentation that meets internal and external regulatory standards.
What We’re Looking For
- A minimum of 5 years’ experience in a regulated environment (ISO 9001/13485), ideally in medical devices or pharma.
- 3+ years’ leadership experience in a quality or engineering capacity.
- Strong knowledge of Six Sigma and SPC principles; Greenbelt certification is a plus.
- Experience with FDA audits, technical writing, and validation processes.
- Familiarity with sterilization and cleanroom environments is highly desirable.