What are the responsibilities and job description for the Sr. Manufacturing Quality Engineering – Systems position at Noah Medical?
About The Team:
The Senior Manufacturing Quality Engineer reports to the Manufacturing Quality Engineering 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 Quality Engineer – 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- San Jose
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
