QMS & CAPA Lead - Medical Device Compliance
Highridge Medical
Highridge Medical in Westminster, Colorado, is seeking a highly skilled Quality Management System Specialist. This role encompasses ensuring QMS compliance with global regulatory requirements and driving CAPA activities. The specialist will also support audits, manage document control, and enhance product quality and patient safety. Candidates must have a Bachelor's degree in a technical field and 3+ years of related experience, particularly in the medical device or pharmaceutical industry. Familiarity with regulatory requirements and strong communication skills are essential. #J-18808-Ljbffr Highridge Medical
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the QMS & CAPA Lead - Medical Device Compliance in Westminster, CO vacancy
- ...FDA-regulated environments. You will manage CAPA, nonconforming materials, investigations, and inspections across the QMS. You will collaborate with Manufacturing, Development... ...Chain, and QA teams to ensure regulatory compliance, process controls, and ongoing improvement...Medical device
$85k - $95k
LivaNova is seeking a Quality Engineer in Arvada, Colorado, to ensure compliance with its quality management system for medical devices. This role involves evaluating non-conforming products, leading CAPA projects, and improving product quality. The ideal candidate should...Medical device$32 - $55 per hour
...Pneuma is seeking a skilled technician to lead manufacturing processes for R&D... ...team, tackle complex tasks, and ensure compliance with production standards. The role demands... ...experience in the biopharmaceutical or medical device industry, with a focus on safety and efficiency...Medical device- XVIVO is seeking a Regulatory Manager to lead regulatory activities for the US market across the full product lifecycle, ensuring compliance and coordinating with cross-functional teams. The role is based in Golden, CO and reports to the Quality & Regulatory Director, driving...Medical device
- ...Quality Management System (QMS) complies with global... ...(eQMS) related to CAPAs and NCs, drives corrective... ..., and regulatory compliance. In addition, the position... ...requirements. Lead and maintain the HHE and... ...g., CQE, CQA, etc.). Medical Device regulations experience...Medical device
$15 - $30 per hour
...been granted a Breakthrough Device Designation by the FDA. Cerapedics... ...closely with Marketing, Medical Education, and Sales Training... ...Foster a culture of integrity, compliance, and disciplined selling.... ...core spine. Prior experience leading a region or area with revenue...Medical deviceFull timeWork at officeWorldwide- ...documents . Perform QMS harmonization by... ...controlled documents. Lead Gemba Walks ,... ...actions. Support CAPA, quality documentation,... ...improvements, and regulatory compliance. Collaborate with... ...Experience: 7-10 years in Medical Device Quality Engineering...Medical deviceLocal area
Artech
Louisville, CO18 hours ago - ...Manager to oversee daily accounting operations and ensure compliance with U.S. GAAP. You will lead the month-end close processes and mentor staff in a... ...experience in accounting, preferably in the medical device or healthcare industry. This position requires 100% onsite...Medical device
- ...CAD Sr Designer Highridge Medical creates the world's most innovative spinal solutions... ...Demonstrated ability to ensure product and process compliance with applicable Quality Assurance and Regulatory requirements in the medical device industry Ability to manage and set...Medical deviceWork at office
Highridge Medical
Westminster, CO18 hours ago - ...documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to... ...Preferred) Minimum of 2 years of experience in orthopedic or medical device industry.* (Required) A minimum of 5-7 years of experience in...Medical device
High Ridge
Westminster, CO2 days ago - EPM Scientific is seeking a Regulatory Affairs professional in Denver, Colorado, to lead global compliance systems and labeling operations within a medical device and biologics organization. This role encompasses full lifecycle support of products with a focus on regulatory...Medical device
- ...Biomet's Norfolk, Virginia site seeks a Site Quality Leader and Management Representative to direct the quality function at a medical device design and manufacturing site. You will utilize quality statistics to develop strategies that sustain and enhance product quality...Medical device
- ...candidate will be responsible for overseeing project methodologies, leading core teams, and enhancing product development processes. Must... ...of experience in new product development, preferably in a medical device sector. Strong leadership and communication skills are...Medical devicePart time
$20 per hour
...hiring immediately for a full time FOH LEAD SUPERVISOR position. Location : Amira... ...Upholds policies and procedures to guarantee compliance with company and client expectations.... ...offer the following benefits to associates: Medical, Dental, Vision, Life Insurance/AD, Paid...Hourly payFull timePart timeLocal areaImmediate startRemote workFlexible hoursCompass Group, North America
Arvada, CO2 days ago- ...seeking a Quality Control Coordinator to ensure quality compliance and document control for QMS and construction projects. Candidates should have 3-5+... ...quality standards. The position offers benefits such as medical insurance, a 401(k) retirement plan, and paid time off....Work at office
- CONFLUENT MEDICAL TECHNOLOGIES INC. is seeking a Senior Manager, Value Stream for its Materials business at the Fremont, CA site. The... ..., coordinating with cross-functional teams, and ensuring compliance with health and safety regulations. A strong project management...Medical deviceShift work
$120k - $160k
...one of our clients, a leading global ingredient manufacturer... ...of global quality and compliance, providing vision and... ...Management System (QMS), ensuring full... ...continuous improvement tools (CAPA, SPC, DMAIC) to drive... ...dietary supplements, medical devices). At least 5 years...Medical deviceLocal areaImmediate start- ...A leading orthopedic device company is seeking a Regulatory Affairs Specialist in Westminster, Colorado. The role involves preparing submissions, contributing to product strategy, and ensuring compliance with regulations. Candidates should have a Bachelor's degree in life...Medical deviceFull time
High Ridge
Westminster, CO2 days ago - ...Roles & Responsibilities: Lead new product development from proof-of-concept... ...support audits, inspections, and regulatory compliance activities Ensure adherence to ISO... ...design experience, preferably in medical devices within a regulated environment Proficiency...Medical deviceContract work
Katalyst Healthcares and Life Sciences
Northglenn, CO1 day ago $197k - $285k
...seeking a Senior Director, Quality to lead its quality organization. In this pivotal... ...product quality strategies, manage compliance with FDA and ISO regulations, and oversee... ...experience in quality management within the medical device or pharmaceutical sectors, along with...Medical device- ...and scale the AS9100‑compliant QMS for complex space missions. The role will drive audits, CAPA, and ensure traceability across... ...internal and external customers, lead customer and supplier visits,... ...for leadership while maintaining compliance with AS9100 and customer...
$100k - $150k
...Build Manufacturing is looking for a hands-on Quality Manager to lead the setup of Minimum Automotive Quality Management System... ...candidate will oversee the entire quality management system to ensure compliance and customer satisfaction. Responsibilities include managing...- ...Accounts Payable and Accounts Receivable.· Lead the month-end, quarter-end, and year-... ...controls to enhance efficiency and compliance.· Support ERP system enhancements, process... ...functions.· Experience in the medical device, healthcare, or manufacturing industry...Medical deviceWork at office
- Katalyst CRO is seeking a Design Quality Engineer (DQE) in Denver, Colorado. The DQE will ensure product compliance with regulatory standards and quality requirements. This role collaborates closely with R&D and manufacturing to embed quality in product design. Candidates...Medical device
- ...for ensuring the quality and compliance of our products and... ...FDA regulations within the medical device manufacturing process for our... ...medical devices. This includes leading and conducting quality investigations... ...and preventive actions (CAPAs) to address quality issues and...Medical devicePermanent employmentTemporary work
Brightpath Associates LLC
Denver, CO6 hours ago $130k - $160k
...mission forward. As a global medical technology leader for... ...function a medical device design and manufacturing... ...and regulatory compliance. Partner with R&D, supply... ...Build, mentor, and lead a high-performing quality... ...investigations into deviations, CAPA (Corrective and...Medical deviceHourly payWork experience placementFlexible hoursZimmer Biomet
Denver, CO2 days ago- ...ensure strong performance. Lead team execution and prioritize... ...Monitor capacity, demand, and compliance metrics (e.g., time reporting... ...experience. Experience in the medical device, healthcare, or life sciences... ...Quality Management Systems (QMS) or similar quality systems...Medical device
- ...Shift Lead JOB TITLE: Shift Lead FLSA STATUS: Non-Exempt JOB STATUS: Full Time... ...all required certification and regulatory compliance standards applicable to the role as... ...assistance you are requesting. Do not include any medical or health information in this email. The...Full timeLocal areaShift workAfternoon shift
Cobblestone Auto Spa|Car Wash
Thornton, CO4 days ago - ...sales strategies across various healthcare entities. The ideal candidate will have a strong background in medical capital equipment sales and the medical device industry. This position offers a competitive salary and comprehensive benefits package. #J-18808-Ljbffr FujifilmMedical deviceRemote job
- ...treatment. As a Regional Manager, you will lead a trailblazing team of interventional... ...it is a hybrid of pharmaceuticals and medical devices. This is an opportunity to lead a... ...effectiveness and administration to ensure compliance with all policies and procedures. Requirements...Medical deviceWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QMS & CAPA Lead - Medical Device Compliance. Be the first to apply!
Related searches
- medical device Westminster, CO
- compliance technician Westminster, CO
- compliance team leader Westminster, CO
- legal compliance Westminster, CO
- export compliance Westminster, CO
- entry level regulatory affairs Westminster, CO
- entry level compliance Westminster, CO
- customs compliance Westminster, CO
- compliance Westminster, CO
- regulatory compliance Westminster, CO