Manager, Quality Engineering

3 weeks ago

San Jose, United States Noah Medical Full time

A Day In The Life Of Our Manager, Quality Engineering

Product Acceptance and Release:

Ensure manufacturing processes and products consistently meet internal quality standards and regulatory requirements.

Lead all aspects related to product acceptance and release activities.

Implement and maintain robust quality control measures to uphold a high standard of product quality.

Process Validations and Continuous Improvement:

Guide and lead the team during the product development phase, emphasizing process validations.

Investigate and address nonconformances promptly to promote a culture of continuous improvement.

Manage changes in the manufacturing process with a focus on quality, ensuring proper validation and documentation.

Quality Oversight and Program Management:

Ensure the quality oversight of manufacturing processes, production test methods/specifications, and finished product release activities.

Establish and manage the Product Bioburden program, emphasizing the importance of quality at every stage.

Partner with manufacturing to ensure appropriate facilities for the production of medical devices are established and maintained.

Collaborate effectively with contract manufacturers and critical subcontractors to ensure seamless alignment with quality standards.

Sterility Assurance and Annual Validations:

Oversee sterility assurance processes, emphasizing the importance of integrity and sterility in medical devices.

Plan, execute, and document annual sterilization validations, reinforcing adherence to regulatory guidelines.

Team Leadership and Development:

Provide visionary leadership to a team of engineers and quality professionals.

Foster a culture of continuous improvement and adherence to quality standards.

Actively coach and mentor staff on the principles of quality excellence.

Establish strong working relationships to ensure product quality at every stage of the manufacturing process.

Collaboration and Cross-Functional Projects:

Collaborate with cross-functional teams on qualification, process capability, and process improvement projects.

Encourage a collaborative approach to quality initiatives.

Quality Culture Advocacy:

Actively champion a quality culture throughout the organization.

Provide hands-on guidance and leadership to instill a commitment to quality in all team members.

Participate enthusiastically in QE/QMS activities, contributing to the overall quality culture.

About You:

BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent.

Minimum of 8 years of work experience in the medical device field with at least 2 years of supervisory or management experience.

Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements.

Management experience in inspection/test method development and validation.

Experience with Risk Analysis, FMEAs, Hazard Analysis, GD & T requirements.

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, Jama, 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.

Preferred but not required: experience with Software Validation, with both disposable/sterile devices and capital/electronic equipment.

Certifications: ASQ CQE certifications, 6 Sigma, ISO Auditing, etc., are a plus

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

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