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Quality Integration Manager

Company: Endologix
Location: Santa Rosa
Posted on: November 19, 2021

Job Description:

Careers - Endologix - Quality Integration Manager in Santa Rosa, California - Careers at Endologix, SR Skip Branding

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          • Our Locations Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status, or any other characteristic protected by applicable federal, state, or local law. In addition, Endologix will provide reasonable accommodations for qualified individuals with disabilities. If you'd like more information about your EEO rights as an applicant, please click here .

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            • Terms & Conditions CONNECT ON SOCIAL MEDIA: Endologix products and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability.
              Prior to use, refer to the "Instructions for Use" for complete and specific indications, contraindications, all warnings and precautions. Rx only.-- 2016 Endologix, Inc. All Rights Reserved. Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Quality Integration Manager Job ID 2021-2578 Location US-CA-Santa Rosa Additional Locations US Category Quality Overview Responsible for planning and execution of QMS integration, ensuring timely and compliant execution with overall project needs. The qualified Integration Manager will provide leadership in establishing, implementing, and maintaining Quality System processes and documentation in compliance with domestic and international Regulatory and Quality standards by performing the following duties personally or through subordinates.Preference will be given to candidates in the SF Bay Area who are able to commute by car on a regular basis to our locations in the Bay Area (Santa Rosa and Milpitas). This position will require regular travel if it is homebased. Travel to company headquarters in Irvine will be required periodically. Responsibilities
              • This position is a key member of the cross-functional team and will drive quality related processes and systems management to enable successful QMS integration.
              • As part of integration, this position will also have responsibilities over on-going Quality Operations during and post the integration process.
              • Responsible for planning and execution in such manner that mitigates quality and regulatory compliance risk while adhering to overall project requirements and timelines
              • Ensures that Quality System processes are compliant with applicable domestic and international Regulatory and Quality standards.
              • Ensures that company employees are trained on applicable regulations, both domestic and international regulations and standards.--
              • Coordinates and ensures that all aspects of the QMS are being followed and performed in a timely manner
              • Acts as advisor to subordinate staff and cross functional team members to help meet established schedules or resolve issues.
              • Maintains information in various compliance databases and produce reports as needed.
              • Provides reports on the status of the Quality System to executive management by supporting preparation of Management Review presentations.
              • Participates in regulatory inspection activities. Communicates with FDA and International ministry of health officials as assigned.
              • Maintains an up-to-date knowledge in applicable domestic and international regulations and standards, as well as company products and process technologies.
              • Identifies and reports risk trends to management.
              • Normally receives no instructions on routine work, general instructions on new assignments.
              • Perform other duties as assigned by supervisor. Qualifications
                • Demonstrated understanding and ability to interpret regulations and guidelines governing medical devices including QSR's, ISO 13485, EU MDR, and MDSAP.
                • Demonstrated understanding of QMS integration and development activities.
                • Proficient knowledge of Master Validation Plans and implementation.
                • Strong communication and organization skills required. Ability to communicate with team members, peers, and leadership.
                • Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
                • Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
                • Proficient knowledge and use of MS Office suite (MS Word, MS Excel, MS Project, MS PowerPoint)
                • Proficient knowledge of Program Management Education:
                  • Bachelor's degree in a scientific discipline or equivalent from a four-year college or university. Experience:
                    • Eight years' experience in Class II or Class III Medical device industry experience with a bachelor's degree or six years with a PhD or Master's
                    • Strong experience leading programs within Quality Systems or Quality Assurance
                    • Experience leading virtual teams
                    • Knowledge of the product lifecycle model Options Apply for this job online Apply Share Email this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Application FAQs Software Powered by iCIMS
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Keywords: Endologix, Santa Rosa , Quality Integration Manager, Executive , Santa Rosa, California

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