About this role
General Summary
The Quality Supervisor II leads the Quality Control (QC) inspection team to ensure inspection activities are properly prioritized, executed, documented, and compliant with applicable manufacturing requirements, quality procedures, regulations, and standards. The role supports efficient daily operations by aligning resources, resolving inspection-related issues, developing team capability, and partnering with Operations, Engineering, Planning, and other stakeholders to meet business needs without compromising product quality or compliance.
Qualifications
- Bachelor’s degree in engineering with 4+ years of experience in the fields of Quality, Biomedical, Life Sciences, Physical Sciences, Engineering, or equivalent combination of education and experience.
- 2+ years of experience in a Lead/Rotational Supervisory role desired
- Solid problem analysis and decision-making ability and leadership skills
- Strong oral, written and interpersonal communication skills required
- English Level: B2 (MCER) – Intermediate proficiency required.
- Knowledge and understanding of FDA QSRs, ISO standards, and applicable medical device regulatory requirements
- Knowledge of sterilization requirements for medical devices preferred
- Knowledge of controlled environments for medical devices preferred
- Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint)
- ASQ certifications for CQIA, CQA, or equivalent preferred
- High degree of accuracy and attention to detail