Quality Systems Director: ISO 9001/AS9100 & Audits
Stratasys
Stratasys is seeking a Quality Systems Director to lead the global quality program for manufacturing. You will standardize processes, align inspection methods to customer requirements, and educate internal and external customers on additive manufacturing quality expectations. You will manage QA operations across sites, oversee audits (ISO 9001, AS9100), drive continuous improvement, and report quality metrics to senior leadership. Travel about 25% is expected. #J-18808-Ljbffr Stratasys
- Stratasys, a leader in additive manufacturing, seeks a Quality Systems Director to elevate our SDM manufacturing to best-in-class... ...educating internal and external customers, maintaining ISO 9001 and AS9100, leading audits, and delivering measurable quality improvements...Suggested
- ...Full Time Indirect New Hope, MN, US Quality Systems Manager About Lake Air Products Lake Air Products... ..., certification readiness, and audit activities, leading corrective action programs... ...'s subject matter expert for ISO 9001, ISO 13485, AS9100, customer-specific requirements...SuggestedPermanent employmentFull timeContract workTemporary work
$120k - $150k
...NPI Quality Program ManagerAdvanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly... ..., and Six Sigma methodologies. Strong knowledge of ISO 9001 or similar quality management systems. Experience using project management, data analytics,...SuggestedContract workTemporary workWork at officeFlexible hours- ...Gradian Thermal Solutions seeks a Quality Manager in Maple Grove, MN to lead and continuously improve our ISO 9001 certified QMS for data center cooling products. You will oversee QA/QC, CAPA, audits, and KPIs to ensure product reliability and regulatory compliance. Responsibilities...Suggested
- ...chains, and improve patient care. The Quality Systems Director will be responsible to oversee and move... ...concerns. Oversee 3rd party registrar audits for all manufacturing sites. Ensure... ...and maintaining quality systems such as ISO 9001 & AS9100. Audit and recommend course...SuggestedLocal areaShift work
$170k - $270k
JOB DESCRIPTION Job Title Director, Quality Management Systems & Compliance Job Description The... ...System (QMS) initiatives, drive audit/inspection readiness, and ensure high... ...deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$97k - $123k
...Quality Systems ManagerQTS offers critical end-of-line services for medical device OEMs including... ...Take the lead in second and third-party audits, including audit preparation, execution,... ...system which meets the requirements ISO 13485, and FDA QSR.Manage CAPA facilitators...Full timeTemporary workWork experience placementWork at officeLocal area$120k - $145k
...Quality ManagerThis role leads day-to-day quality operations in a highly... ...frame shape-setting, delivery system fabrication, and cleanroom... ...ensure a continuous state of audit readiness, and support the organization... ..., 21 CFR Part 820, applicable ISO standards, and relevant...Permanent employmentLocal area$120k - $145k
...Job Title: Quality ManagerJob Description This role leads day-to... ...frame shape-setting, delivery system fabrication, and cleanroom packaging... ...ensure a continuous state of audit readiness, and support the... ..., 21 CFR Part 820, applicable ISO standards, and relevant international...Permanent employmentLocal areaFlexible hours$102.1k
...Recruiter: Spencer Gregory Hale Quality System Manager About the role: As the... ...Support internal and external audits and inspections by providing Management... ...regulations/standards such as 21 CFR 820 and ISO 13485 Preferred qualifications:...Hourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- ...lead generative AI-enabled automations and digital solutions across Global Quality Assurance and Regulatory Affairs. The role manages global AI software implementations across quality systems, ensuring alignment with validation and lifecycle requirements. The hybrid role...Work at officeRelocationVisa sponsorship3 days per week
$130k - $160k
...And by harnessing Danaher’s system of continuous improvement,... ...makes everything possible.The Quality Assurance Manager,... ...Chaska, MN and reports to the Director of Quality Assurance. Our analyzers... ...Quality Management System ISO 13485:2016 and ISO 9001:2015This experience is a...Full time$160k - $180k
Manager, Operational Quality Plymouth, MN55441 Posted: 08/19... ...objectives through effective quality systems, continuous improvement... ...Quality System Regulations (QSR), ISO 13485, EU MDR, and other... ...regulatory inspections and external audits, including FDA and notified...Permanent employmentContract workWork at officeLocal areaFlexible hours$120k - $150k
...- powering the future, together.POSITION SUMMARY:The Quality Program Manager, NPI plays a critical role in ensuring... ..., and Six Sigma methodologies.Strong knowledge of ISO 9001 or similar quality management systems.Experience using project management, data analytics,...Contract workWork at officeFlexible hours- ...Jobtailor is seeking a CAPA Quality professional to lead investigations, root cause analyses, and corrective actions in a regulated medical device environment. You will coordinate recalls, advisory notices, field actions, and post-market actions while developing metrics...
$134.16k - $167.69k
...Description TheSenior Quality Managerfor Safco Products... ...the Quality Management System (QMS), ensuring... ...position reports to the Director of Operations and is located... ...customer, and supplier audits, ensuring timely resolution... .... Strong knowledge of ISO 9001 quality systems,...Work at officeFlexible hours$74.16k - $91.61k
...Quality Control SupervisorThe Quality Control Supervisor in our Plymouth, MN location leads... ...In addition, as a contributor to Quality System compliance, the Quality Supervisor... ...to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/2...Temporary workWork at officeLocal areaMonday to FridayShift work- ...Quality Systems ManagerThe Quality Systems Manager is responsible for strategy, deployment, alignment, and maintenance of the Quality Management... ...continual compliance of the organization. The role owns the audit, certification, and relationship maintenance of the company's...
- ...within the role of the Quality Assurance Manager will... ...and/or stated standards (ISO & FDA); to continuously... ...third party quality audits as required; manage and... ...implementation of Quality Systems and trainingAct in... ...working knowledge of ISO 9001:2015 and ISO 13485:201...
$100k - $120k
...within the role of the Quality Assurance Manager will... ...and/or stated standards (ISO & FDA); to continuously... ...third party quality audits as required; manage and... ...implementation of Quality Systems and training Act in... ...working knowledge of ISO 9001:2015 and ISO 13485:201...$97.9k - $146.9k
...Join to apply for the Quality Manager role at QTS Medical... ...QTS Quality Management System. This role will support... ...alignment with the FDA QSR and ISO requirements and utilize... ...customer, internal, ISO 9001:2015 and EN ISO 13485:2... ...for customer audits, and support external audits...Full timeTemporary workLocal areaRelocation package- ...industry.Position OverviewWe are seeking a Quality Manager to lead, maintain, and... ...continuously improve our quality management system (QMS) within our ISO 9001 certified manufacturing facility... ..., and third-party registrar quality audits.Formulate and maintain quality...Work at office
- ...talent pool and grow with H 2 O. Overview The Quality Manager will lead the development and execution of quality systems for the Water Technologies & Services (WTS) Division... ...margins, while building the foundation for ISO 9001 certification and long-term quality system...Flexible hours
$75k - $112.6k
...responsibility is the execution of core Quality System processes, including... ..., training compliance, and audit readiness. The Supervisor... ...in Quality Assurance ~ ISO 13485/ISO 9001 ~ Quality systems... ...to help you whether it is a director, a machinist, or your boss....Hourly payContract workTemporary workWork at officeLocal area- ...Perform the activities associated with the systems engineering of one or more products in... ...needs, regulatory standards, human factors, quality, manufacturing, service, etc. Use... ...within the project Drive adherence to FDA, ISO and IEC design control procedures, regulations...Remote workShift work
- ...Reference26-00979Remote50% RemoteSummaryThe Systems Engineer will support the overall... ...from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)Drive system... ...stakeholdersEnsure compliance with FDA, ISO, and IEC design control standardsUtilize...
$108k - $148k
...Our in-home Peritoneal Dialysis (PD) systems are used around the world to support patients... ...needs, regulatory standards, human factors, quality, manufacturing, service, etc. Use... ...the project Drive adherence to FDA, ISO and IEC design control procedures, regulations...Temporary workWork from homeWorldwideFlexible hoursShift work3 days per week$31 - $34 per hour
...More than one million tests are run on our systems every hour, benefiting 1.2 billion... ...million clinicians annually. The Analyst I Quality Assurance, Calibration Coordinator is responsible... ...equipment. Knowledge of 21 CFR 820.72, ISO 9001, ISO 17025 and ANSI/NCSL Z540 in a...Hourly payLocal areaWorldwide- ...Description Job Description Quality Assurance Manager... ...Managing the following: ISO / AS9102, MIL-SPEC 55110... ...criteria, quality system and performance ability... ...contact for “on-site” quality audits & surveys from customers... ...management systems (ISO 9001, AS9100, etc.). Proficiency...
$181k - $288k
Job TitleDirector, Quality & Regulatory- Mergers & Acquisitions (M&A)Job DescriptionThe Director, Quality & Regulatory M&A is an enterprise... ...related to external audit findings, FDA 483 observations... ...commitments, and internal quality system requirements.Lead QMS transition...Full timeWork at officeImmediate startWork visaRelocation package3 days per week
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