Staff Quality Engineer - California, United States - Noah Medical
Description
About The Team:
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.
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 Staff Quality Engineer:
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, 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.
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.
Other related assignments and support for manufacturing
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 7+ years of Engineering work experience in the medical device field and a minimum of 4 years' experience in a QE/Mfg.
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.
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.
Experience with sterilization processes.
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
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