Sr. Manufacturing Quality Engineering – Systems

About The Team:

The Manufacturing Quality Engineer reports to the Manufacturing Quality Engineering Lead or equivalent manager. This position provides hands-on guidance and leadership from a Quality and Regulatory perspective to the team throughout the product development cycle, especially with V&V and Design Transfer stages. The focus is to provide engineering support so high-quality products can be produced in a world class manufacturing infrastructure. We are looking for someone that is highly motivated in their career growth, a self-starter, a team builder, and an excellent communicator.

The role will collaborate closely with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, meet customer demands, improve processes, support NPI, scale production, improve the factory, own safety and facilities, while maintaining high-quality standards.

A Day In The Life Of Our Sr Manufacturing QE – Systems :

• 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.

About You:

• Education: 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.

Workplace Type: Onsite

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