Quality Manager, Medical Devices & Compliance
Halma plc
Volk, a leading ophthalmic lens brand under Halma, seeks a Quality Manager in Mentor, Ohio. You will lead the Quality team, drive continuous improvement, and ensure ISO 13485 and FDA QSR compliance. You will own audits (ISO, FDA, customer), CAPA, and data-driven quality metrics. You will influence cross-functional teams and guide risk management, design controls, and verification/validation activities to ensure top quality and regulatory adherence. #J-18808-Ljbffr Halma plc
- ...Quality Manager Volk is the world's leading brand in ophthalmic diagnostic... ...improve the QMS in compliance with ISO 13485, FDA Quality... ...customer audits; experience in medical manufacturing Analyze quality... ...(21 CFR §820), and medical device compliance requirements...Medical device
- Volk Optical Inc. seeks a Quality Manager to lead the Quality team and drive excellence in a regulated manufacturing setting. You will oversee the QMS, ensure compliance with ISO 13485 and FDA QSR 21 CFR 820, and coordinate internal and supplier audits while reporting critical...Medical device
- ...and a subsidiary of Halma, seeks a senior Quality leader to drive the Quality Management System and regulatory compliance. You will oversee CAPA, audits, and continuous... ...requires extensive experience in regulated medical device environments, strong data analytics, and...Medical device
- ...President, Internal Audit & Corporate Compliance About the Company Global provider... ...infection prevention Industry Medical Devices Type Public Company Founded... ...corporate compliance, and enterprise risk management programs. The successful candidate...Medical device
$224.5k - $246.95k
...SummaryThe VP, Internal Audit & Compliance leads STERIS’s internal... ...compliance, and enterprise risk management programs. This role provides... ...a global, publicly traded medical device organization. As a strategic... ...the Chief Complieance and Quality Officer and senior leadership...Medical deviceTemporary workFor contractorsWork at officeLocal area- North American Coating Labs in Mentor, OH is seeking a Quality Specialist who loves root-cause analysis and clean audits. You will own our QMS, ensure ISO 9001 alignment, and keep data handling compliant with CMMC standards. You will lead internal audits, coordinate with...
- Job Title: Human Resources Manager, Corporate TechnologyJob Type:... ...and programs.Coach managers on compliance, employment laws, and... ...Defined ContributionComprehensive medical, dental & vision coverageHealth... ...coatings, and skincare to medical devices and plumbing systems —are...Medical deviceWork at officeFlexible hours
- ...Manufacturing Technology, Quality and Continuous... ...reviews, performance management & succession planning,... ...standards, consistency, and compliance across policies,... ...Contribution Comprehensive medical, dental & vision coverage... ...skincare to medical devices and plumbing systems —...Medical deviceFull timeTemporary workWork at officeLocal areaRemote workFlexible hoursShift work
- ...Function and Purpose of Position: ** The Quality Manager is responsible for the development,... ...supports accident investigations, and teaches compliance with safety regulations and programs.... ...Generous Company Match ~ Bonuses ~ Medical, Dental, and Vision Benefits ~ Paid...Local area
- ...injection molding machines and support Lean manufacturing in a medical device setting. You will verify machine parameters before start‑ups... ...‑down, record data electronically, and conduct in‑process quality verifications to meet ISO 13485 and FDA expectations. You will...Medical deviceAfternoon shift
- ...Reports to: Chief Medical Officer Job Overview... ...interactions, and ongoing compliance with applicable U.S. and... ...while ensuring high-quality execution of submissions... ..., and lifecycle management activities. Translate... ...experience in the medical device, diagnostics, or IVD...Medical deviceTemporary workWork at officeFlexible hours
- ...assembliesCollaborate with cross-functional teams on quality and long-term reliabilityLead key... ...term center stabilityMaintain compliance with Quality related to medical device regulations and requirementsOther... ...supervisionExcellent time management skills and the ability to balance...Medical device
- ...Make an Impact As a Records Compliance Analyst , you’ll drive records management operations and enterprise compliance... ...Contribution ~ Comprehensive medical, dental & vision coverage ~... ...coatings, and skincare to medical devices and plumbing systems —are powered...Medical devicePart timeWork at officeFlexible hours
- ...you will perform assembly work in a station or line to produce medical devices in an FDA regulated and controlled environment. Shift: 1st... ...at or above production targets 2. Handle and evaluate quality of small parts during manufacturing processes. 3. Inform Team...Medical deviceTemporary workShift work
- ...Competitive wages based on experience ~ Quality medical, dental, vision, and life insurance... ...Intermediate math skills Ability to manage multiple priorities and tasks with a sense... ...assembly, welding, packaging, medical devices, and many other industries. We...Medical deviceBi-weekly payHourly payFull time
- ...Job Description Job Description Quality Assurance Manager Location: Kirtland/Mentor, Ohio area J ob Type: Full-Time | Direct Hire A growing manufacturing organization is seeking an experienced Director of Quality Assurance to lead its quality function...Full time
- ...forward-thinking Maintenance Manager to lead and elevate the... ...such as preventive maintenance compliance, equipment reliability, downtime... ...degree. Experience within medical device, highly regulated... ..., life sciences, or similar quality-driven industries. Exposure...Medical deviceMonday to FridayShift workDay shift
$144.5k - $187k
...ensures the delivery of scalable, high-quality engineering solutions that enable business... ...capability.Financial ManagementOwn and manage the engineering operating budget (~$5-7M... ...or consumable products industries (e.g., medical device, aerospace, defense, industrial...Medical deviceTemporary workFor contractorsWork at officeLocal areaRemote work- ...you will be responsible for performing high mix/ low volume manual TIG welding of Stainless Steel and Aluminium in a high-quality medical device manufacturing environment. Shift: Monday-Thursday 7:00am-4:30pm and Friday 7:00am-11:00am What you will do as a Welder...Medical deviceTemporary workShift work
$107.53k - $139.15k
...7Position SummaryThe Product Manager position is a mixture of downstream... ...Customers, R&D, sales, quality, regulatory, finance, operations... ...is helpfulMedical device product marketing experience... ...pregnancy, childbirth and related medical conditions), sexual orientation...Medical deviceTemporary workFor contractorsWork at officeLocal area3 days per week$107.53k - $139.15k
...SummaryThe Downstream Market Manager is responsible for commercializing... .../sector experienceMedical device marketing experience... ...conflicting deadlines while delivering quality work on timeProven experience... ...or commercial marketing (medical device or healthcare industry...Medical deviceTemporary workFor contractorsWork at officeLocal area3 days per week$140k - $160k
...(ORI) software as a Senior Manager, Software Engineering. In this... ...and ensure software compliance with design standards and product... ...developer productivity, code quality, and speed-to-marketCreate and... ...a plusExperience within the medical device industry Experience with...Medical deviceTemporary workFor contractorsWork at officeLocal area- ...Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our... ...medical devices that ensure that we meet our customer's quality specifications for each product we produce. We are looking...Medical deviceNight shift
$15.02 - $19.44 per hour
...you will perform assembly work in a station or line to produce medical devices in an FDA regulated and controlled environment. Shift: 10:... ...at or above production targets Handle and evaluate quality of small parts during manufacturing processes. Inform Team...Medical deviceTemporary workLocal areaShift workNight shift$92.65k - $119k
...Senior Quality EngineerThe Senior Quality Engineer in our Mentor, OH location is responsible for managing processes and leading projects to maintain and improve the quality system... ...certified environment.Experience with medical device or other regulated industries.Quality...Medical deviceTemporary workLocal areaMonday to Friday- ..., high-performance, and cost-effective medical devices with a particular focus on high growth... ...that ensure that we meet our customer's quality specifications for each product we produce... ...key drivers for variances to site management team Generates weekly site spend reporting...Medical device
$81.75k - $109k
...Design, develop, and execute software verification tests for medical devices following STERIS work instructions. Analyze software... ...issues. Continuously improve verification processes to enhance quality, compliance, and productivity by adapting modern technologies like AI...Medical deviceTemporary workFor contractorsLocal area3 days per week$22.34 - $24.28 per hour
...Welder you will be responsible for performing high mix/low volume manual TIG welding of Stainless Steel and Aluminium in a high-quality medical device manufacturing environment. Shift: Monday-Thursday 7:00am-4:30pm and Friday 7:00am-11:00am What You Will Do As A...Medical deviceTemporary workFor contractorsWork at officeLocal areaShift workDay shift$145k - $160k
...support. Responsible for people management within the Engineering... ...Responsible for the validation compliance for all internal operations.... ...from the Value Streams, Quality, R&D, Purchasing, and Engineering... ...efforts of all drug and medical device products manufactured in-house...Medical deviceTemporary workFor contractorsWork at officeLocal area- ...Essential Job Functions: Ensure compliance with all environmental,... ...in order to manufacture quality product in a safe and efficient... ...effectively with team and management to create a professional and... ...mechanical aptitude • Experience in medical device or pharmaceutical...Medical deviceLocal areaImmediate startWorldwideFlexible hoursShift workNight shift
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