Director, Quality Assurance and Management Rep.

Job Description

• Establishes Quality department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones. • Involved in developing, modifying and executing Quality related company policies, which affect immediate operation(s) and may also have company-wide effect. • Manages the Quality department functions through direct reports or subordinates • Leads/Supervises operating budget and employees. • Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations. • Responsible for defining, training and implementing the quality management system (QMS) at Noah Medical and for the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements. • Coordinates the planning, promotion and organization of quality, regulatory and reliability engineering activities, including Design/Development/NPI, DHF/DMR/DHR documentation, supplier qualification, manufacturing, and distribution control. • Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions. • Serves as the designated Management Representative • Other management activities not specified and as assigned

Qualifications

• Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. • Minimum of 10 years of Quality related experience in the medical device field (experience in capital equipment and services a plus) • Minimum of 3 years of supervisory experience of multiple exempt level employees • Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams • Experienced in implementing a complete QMS system to meet US FDA and ISO requirements • Experienced in conducting internal and supplier audits and hosting 3rd party audits • Experience with quality tools such as Risk Analysis, FMEA, GD&T, Process Validation, statistical applications, and data analysis/metric presentation techniques • Must be a self-starter, team builder, and excellent in verbal and written communication • Preferred: Knowledge of sterile/disposable medical device production processes • Preferred: Master Degree, MBA, experienced with Software Validation • Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc • Preferred working proficiency in Chinese but not required

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