![Noah Medical](https://media.trabajo.org/img/noimg.jpg)
Sr. Quality Systems Manager
4 weeks ago
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team:
Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together
The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. They coordinate projects and takes a role in the design and execution of processes. They will design, implement, maintain, and enhance Quality Systems company-wide.
A Day In The Life Of Our
Sr. Quality Systems Manager
:
Assist with implementing and enhancing the Quality Management System in line with certifications, regulations and business requirements.
Lead quality system processes such as: CAPA, training, GxP systems, external standard and record management, change management, and internal audits.
Work closely with cross-functional departments to ensure that the deployment of GxP systems meets company standards and relevant regulations and that systems are maintained in a validated state.
Collaborate with stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows.
Assess QMS processes for potential gaps to ensure compliance with regulatory guidelines.
Responsible for the management of the eQMS including workflow configuration and upgrades as needed.
Collaborate with stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows.
Review and approve procedures, work instructions, and other governing documents to support Noah’s QMS.
Act as a Subject Matter Expert (SME) and provide guidance and training on quality events, including but not limited to change control, audit findings, investigations, and CAPA’s.
Drive timely completion of Quality System deviations, CAPAs, internal audit actions, and change controls.
Implement training programs associated to the quality management system
Establish, compile, track, and present Quality Metrics to support Quality Management Review
Participate in regulatory inspections and/or internal audits representing Quality System
Ensure that CAPAs resulting from audits associated with the assigned programs and studies are allocated a CAPA owner and closed out appropriately and timely.
Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.
Proactively influence management regarding the implementation and/or adoption of standards to improve quality, efficiency, and compliance
Activity drives awareness of compliance to regulatory certifications, Noah Medical QMS, and customer requirements deploying efficient and consistent procedures.
Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
Strong leadership, communication, and cross-functional collaboration skills.
Recruit, develop, and retain a high-performing team of quality professionals.
Promote a high standard of awareness and understanding at site level of all appropriate policies
As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
Other QMS activities not specified here and as assigned.
About You:
Requires a BS in Engineering or Technology in Mechanical, Industrial, Electrical, life sciences, etc.
Minimum of 10 years of Quality related experience in the medical device field including at least 3 years of medical capital equipment and service/maintenance operations
Minimum of 3 years of management experience of multiple exempt level employees
Strong organizational skills; ability to be pro-active, multitask efficiently, complete tasks on time, and handle deadlines under pressure
Well versed in the complete Quality Management System to meet US FDA and ISO/MDR requirements
Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems.
Excellent verbal and written communication skills and interpersonal skills
Experienced in conducting internal audits and hosting 3rd party audits
Experience with quality tools such as Risk Analysis, FMEA, root cause analysis, statistical applications, and data analysis/metric presentation techniques
Workplace Type:
Hybrid
Benefits & Perks (For Full Time Employees):
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
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Pay Transparency
The Pay Range for this position is listed. Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location of the posted role. Noah Medical reserves the right to modify this range as needed based on candidate experience level and/or specialized skills. Please note that the aforementioned range is only one component of the position's total compensation package.
$159,200
—
$199,000 USD
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
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For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Noah Medical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Noah Medical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
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If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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