Vapotherm
Plan, lead and manage projects, budget and personnel for the Quality Department.
Manage the Quality Department consisting of quality managers, quality engineers, quality inspectors, quality technicians, complaint handling associates, document control associates.
Ensure company remains in compliance with all worldwide quality system regulations.
Ensure all products designed and marketed meet all product related regulations.
Supervise employees to ensure company maintains proper Design Validation and Verification Testing for medical device disposable application per ISO 13485 and 21 CFR 820 and Medical Device Process Validation inclusive of Installation Qualification, Operation Qualification and Performance Qualification following the International Medical Device Regulators Forum (IMDRF) GHTF SG3 guidance.
Supervise employees working on biocompatibility testing for medical devices per the ISO 10993 series.
Ensure company maintains ISO 13485 certified quality management systems along with other quality certifications MDSAP for US FDA, European MDD (93/42/EEC), and European MDR (2017/745). Ensure compliance with other country quality regulations including but not limited to Canada (CMDR), Japan (MHLW Ordinance 169), Brazil (ANVISA).
Ensure Quality Department is adequately resourced in terms of personnel, equipment, facilities by planning resources based on design and development activities, product realization activities and available test capacity.
Ensure appropriate documentation and records.
Represent and assess the health of the quality management system.
Make appropriate changes to quality management system based on the needs of the business.
Experience:
Must have Master's degree or equivalent in Plastics Engineering, or a related field (will accept a Bachelor's degree plus 5 years progressive post baccalaureate experience in lieu of Master's).
Must have 1 year experience (or 1 year experience as Quality Control Manager, Quality Engineer, or related occupation).
Must have 1 year experience working with Design Validation and Verification Testing for medical device disposable application per ISO 13485 and 21 CFR 820 and Medical Device Process Validation inclusive of Installation Qualification, Operation Qualification and Performance Qualification following the International Medical Device Regulators Forum (IMDRF) GHTF SG3 guidance; with biocompatibility testing for medical devices per the ISO 10993 series.
Ensure company maintains ISO 13485 certified quality management systems along with other quality certifications MDSAP for US FDA, European MDD (93/42/EEC), and European MDR (2017/745). Some travel, including international travel, required for Supplier Assessments and Audits.
You may apply directly through our corporate website you may email your resume referencing ID#219 to hr@vtherm.com or mail resume to: HR, Vapotherm, Inc., 100 Domain Drive, Suite 102, Exeter, NH 03833.
About the company
Vapotherm Inc. is a publicly held corporation based in Exeter, New Hampshire that was founded in 1999 as a medical device manufacturer after creating the first heated and humidified high flow therapy nasal cannula system. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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Vapotherm Inc. is a publicly held corporation based in Exeter, New Hampshire that was founded in 1999 as a medical device manufacturer after creating the first heated and humidified high flow therapy nasal cannula system. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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