Sr. Manufacturing Quality Engineering – Systems

Job Description

• Develop and support Product Final Acceptance processes. • Engage in procedure validation and improvement activities. • Provide hands-on leadership and guidance to Design Transfer requirements, Risk Management, Manufacturing processes, incoming and in-process inspection and test methods/specifications, Process Validation (including sterilization), and finished product release activities. • Participate in new product development teams and represent Quality function as needed. Provide relevant input to the product development planning process according to project milestones and QMS implementation /requirements/trace matrix. • Define, implement, and provide training on relevant aspects of Noah Medical’s Quality Management System to meet US FDA and International requirements. • Grow in QE/QMS expertise as defined by the manager. • Participate in QE/QMS activities not specified here and as assigned. • Review equipment documents and ensure all defined requirements are met. • Collaborate well with team members throughout Noah organization. • Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.

Qualifications

• BS degree in a technical field or equivalent. • BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent. • Minimum of 6 years of Engineering work experience in the medical device field and a minimum of 4 years’ experience in a QE/Mfg. function or equivalent. • Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements. • Experience in inspection/test method development and validation for IQC, In-Process, and Final release requirements. • Experience with electro-mechanical assembly. • Experience with SPC and data analysis using six sigma tools. • Experienced with Process Validation including sterilization validation. • Experience in supplier selection, qualifications and improvement. • Experience with Risk Analysis, FMEAs, Hazard Analysis. • Experienced with statistical skills to define/train on test sample size and data analysis techniques. • Experienced in Microsoft Office and other software tools such as Google Suite and ePLM/eQMS systems, or equivalent. • Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication. • Prior manufacturing experience in a medical device company, preferably on surgical robotics or equivalent highly complex medical devices. • Strong team player with proven history of success working in a multi-disciplinary, cross-functional team. • Strong verbal and written skill with the ability to communicate effectively across functions and levels in the organization. • Excellent people and project management skills. • Experience in MRP systems, MS office and related office automation systems. • Experience in Medical Device Design Control processes preferred.

Benefits

• Competitive Salary • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options • Equity & Bonus Program • Life Insurance (company paid & supplemental) and Disability insurance • Mental health support through medical insurance programs • Legal and Pet Insurance • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days • Paid parental leave • In-office snacks and beverages • In-office lunch stipend • Learning & Development Opportunities: On-demand online training and book reimbursement • Team building and company organized social and celebration events