quality manager - medical.
milpitas , california
posted 5 days ago
job details summary
$90,000 - $125,000 per year
permanent
bachelor degree
category production occupations
referenceAB_4641135
job details
The Quality Manager is responsible for leading the quality assurance and control functions within the medical device manufacturing environment.
This role involves overseeing compliance with regulatory standards, implementing quality management systems, and fostering a culture of continuous improvement to ensure the delivery of safe and effective medical devices.
If you're currently seeking employment please email or give us a call today.
Thank you,
salary: $90,000 - $125,000 per year
shift: First
work hours: 8 AM - 4 PM
education: Bachelors
Responsibilities
Quality Management System (QMS): Develop, implement, and maintain the QMS in compliance with ISO 13485, FDA regulations, and other relevant standards.
Regulatory Compliance: Ensure that all products meet regulatory requirements, including preparation for audits and inspections by regulatory bodies.
Team Leadership: Manage and mentor the quality assurance team, providing guidance and training to ensure adherence to quality standards and processes.
Risk Management: Lead risk assessment activities, including FMEA and hazard analysis, to identify and mitigate potential quality issues throughout the product lifecycle.
CAPA Management: Oversee the Corrective and Preventive Action (CAPA) process, ensuring timely and effective resolution of non-conformities and continuous improvement initiatives.
Internal and External Audits: Plan and conduct internal audits; coordinate with external auditors to facilitate compliance assessments.
Quality Metrics: Develop and monitor quality performance metrics (KPIs) to track progress and identify areas for improvement.
Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and regulatory teams to integrate quality principles into product development and production processes.
Training and Development: Provide training on quality processes and regulatory requirements to employees at all levels.
The essential functions of this role include:
working in a smoke free environment
standing for 8 hours at one time
Skills
Quality Assurance
Quality Control
Product Inspection
First Yield Pass
Disassembly
Reassembly
Testing
Inspection
Diagnostic Procedures
Production Control
Qualifications
Years of experience: 3 years
Experience level: Experienced
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.
If you require a reasonable accommodation to make your application or interview experience a great one, please contact ******.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.
In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
get in touch we are here to help you with your questions.
GH
gerardo hernandez fabian +1 408 999 0711 (tel:+1 408 999 0711)
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