Sr. Quality Systems Manager

About The Team:

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. They coordinate projects and takes a role in the design and execution of processes. They will design, implement, maintain, and enhance Quality Systems company-wide.

A Day In The Life Of Our Sr. Quality Systems Manager:

• Assist with implementing and enhancing the Quality Management System in line with certifications, regulations and business requirements.

• Lead quality system processes such as: CAPA, training, GxP systems, external standard and record management, change management, and internal audits.

• Work closely with cross-functional departments to ensure that the deployment of GxP systems meets company standards and relevant regulations and that systems are maintained in a validated state.

• Collaborate with stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows.

• Assess QMS processes for potential gaps to ensure compliance with regulatory guidelines.

• Responsible for the management of the eQMS including workflow configuration and upgrades as needed.

• Collaborate with stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows.

• Review and approve procedures, work instructions, and other governing documents to support Noah's QMS.

• Act as a Subject Matter Expert (SME) and provide guidance and training on quality events, including but not limited to change control, audit findings, investigations, and CAPA's.

• Drive timely completion of Quality System deviations, CAPAs, internal audit actions, and change controls.

• Implement training programs associated to the quality management system

• Establish, compile, track, and present Quality Metrics to support Quality Management Review

• Participate in regulatory inspections and/or internal audits representing Quality System

• Ensure that CAPAs resulting from audits associated with the assigned programs and studies are allocated a CAPA owner and closed out appropriately and timely.

• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.

• Proactively influence management regarding the implementation and/or adoption of standards to improve quality, efficiency, and compliance

• Activity drives awareness of compliance to regulatory certifications, Noah Medical QMS, and customer requirements deploying efficient and consistent procedures.

• Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.

• Strong leadership, communication, and cross-functional collaboration skills.

• Recruit, develop, and retain a high-performing team of quality professionals.

• Promote a high standard of awareness and understanding at site level of all appropriate policies

• As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.

• Other QMS activities not specified here and as assigned.

About You:

• Requires a BS in Engineering or Technology in Mechanical, Industrial, Electrical, life sciences, etc.

• Minimum of 10 years of Quality related experience in the medical device field including at least 3 years of medical capital equipment and service/maintenance operations

• Minimum of 3 years of management experience of multiple exempt level employees

• Strong organizational skills; ability to be pro-active, multitask efficiently, complete tasks on time, and handle deadlines under pressure

• Well versed in the complete Quality Management System to meet US FDA and ISO/MDR requirements

• Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems.

• Excellent verbal and written communication skills and interpersonal skills

• Experienced in conducting internal audits and hosting 3rd party audits

• Experience with quality tools such as Risk Analysis, FMEA, root cause analysis, statistical applications, and data analysis/metric presentation techniques

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

• 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