Quality Manager New Menlo Park, CA

Inquis Medical, Inc.; Menlo Park, Northern (CA, KY); On-site; USD 145,000 - 165,000; Full time

Job summary

Inquis Medical, Inc. is seeking a senior Quality & Regulatory leader to ensure the company’s QMS aligns with California FDB and US FDA QSR requirements.

This role acts independently on all matters affecting product quality and compliance, with authority to initiate corrective actions and supplier disqualification as needed. The position oversees the establishment and maintenance of the QMS, reviews regulatory requirements, and leads CAPA, MRB, and change control processes.

Qualifications

• Four-year bachelor's degree required.
• Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device start-ups preferred.
• Minimum 6 years quality experience in FDA regulated medical devices or related industry.
• Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred).
• Involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired).

Responsibilities

• Establish and Maintain Quality Management System.
• Maintain QMS Manual and associated procedures.
• Review and interpret quality/regulatory compliance requirements and ensure they are implemented through company policies and procedures.
• Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
• Prepare and/or review FDA and other regulatory applications and documents.
• Review and approve all new and changed manufacturing processes to ensure compliance with FDA and QSR requirements.
• Provide support to biocompatibility and environmental control programs.
• Review and approve all product labeling and marketing materials for regulatory compliance.
• Manage Document Change Control
• Manage internal quality audit program
• Manage Medical Device Reporting and complaint management activities
• Develop, implement and supervise NCR and CAPA systems
• Initiate and chair MRB as required
• Ensure training on all released QMS procedures and quality records is current
• Ensure calibration system for all inspection, production and R&D instruments is established and maintained

Skills

Quality management systems

Regulatory compliance

Process improvement

CAPA

Auditing

Education

Bachelor's degree in engineering or related field

Job description

This roleis responsible forensuring the company’s quality system is andmaintaincomplianceCalifornia FDB and US FDA QSR requirements. This position has the responsibility and authority to act independently from the rest of the organization on all matters affecting product quality and compliance. Specifically, this person mayinitiateaction to prevent non-conformities;identifyand document quality problems and initiate, recommend,provideand verify solutions to quality problems. This role may require deliverables from other departments to support FDA Quality Management System requirements; may issue Corrective/Preventive Action Requests to internal departments or suppliers asrequired; mayinitiateSupplier disqualification based on continued unsatisfactory performance.

• Establish and Maintain Quality Management System.
• Maintain QMS Manual and associated procedures.
• Review and interpret quality/regulatory compliance requirements and ensure that they are implemented through company policies and procedures.
• Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
• Prepare and/or review FDA and other regulatory applications and documents, including Medical Device License Applications and Medical Device Reports as required .
• Review and approve all new and changed manufacturing processes to ensure compliance with requirements of FDA and FDB.
• Provide support and guidance to biocompatibility and environmental control programs.
• Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
• Manage Document Change Control
• Manage internal quality audit program .
• Manage Medical Device Reporting and complaint management activities.
• Develop, implement and supervise the non-conformance (NCR) and CAPA systems.
• I nitiate and Chair Material Review Board (MRB) if/as required .
• Ensure training on all released QMS procedures and quality records is current.
• Ensure calibration system for all inspection, production and R&D instruments is established and maintained.

Education / Experience Requirements:

• Four-year bachelor's degree required. Desired in an engineering field
• Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device start-ups preferred
• Minimum 6 years quality experience in FDA regulated medical devices or related industry
• Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device start-ups
• Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred)
• Working knowledge of current FDA Quality Systems Regulation and equivalent international requirements for medical devices.
• Direct, recent involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired)

Compensation Range

$145,000 - $165,000 USD

Inquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.