QMS Specialist Principal Duties and Responsibilities Material Documentation Support and Testing · Implement and maintain the CAPA program including software solutions. · Duties include, but are not limited to, monitoring…
Skills: CAPA Management, Root Cause Analysis, Health Hazard Evaluation, Quality Management Systems, Regulatory Compliance
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
This position will be posted for a minimum of 3 days and will remain open until filled or adjusted based on the volume of applicants. Further your career at Ball, a world leader in manufacturing sustainable aluminum pack…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Please Note: To conform with the United States Government Space Technology Export Regulations, the applicant must be a U.S. citizen, lawful permanent resident of the U.S., conditional resident, asylee or refugee (protect…
Skills: Linux Systems Administration, System Provisioning, Patching, System Hardening, Performance Tuning
Director Business Development (IFM - Manufacturing and Distribution)
Westminster, Colorado, United States · Remote Solely
$150k–$190k/yr
Senior+$360M raised
Company Description WHO ARE WE? Dexterra Group is a fast-growing, financially strong, publicly listed company (TSX:DXT). We have a far-reaching presence across the entire continent North America with hundreds of full-tim…
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REPORTS TO: Director of Program Management FLSA STATUS: Exempt This role offers work from home flexibility while maintaining regular collaboration with onsite teams and customers as business needs require. SUMMARY: The P…
Our growing company is in need of an Account Representative in our Denver Branch. The Account Representative sells company products and services via telephone, internet, e-mail and fax. Works in conjunction with Field Sa…
Skills: Sales, Customer service, Relationship building, Negotiation, Communication
Sr Development Engineer I Principal Duties and Responsibilities: · Contributes to the design and development of new products and improvements to existing products from conception to launch following Design Control proced…
Sr Accountant Job Summary: Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not jus…
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Full-time
bachelor degree, professional certificate
Posted 78d ago
~40 hrs/week
Responsibilities
Implement and maintain the CAPA program, including monitoring problem statements, root cause analysis, and tracking timelines. Lead the Health Hazard Evaluation and Field Action programs while coordinating with regulatory agencies and supporting internal audits.
Requirements
Requires a Bachelor's degree in a technical discipline or a quality certification, with 3+ years of experience in the medical device or pharmaceutical field. Proficiency in quality control techniques and familiarity with medical device regulations are preferred.
Full job description
QMS Specialist
Principal Duties and Responsibilities
Material Documentation Support and Testing
· Implement and maintain the CAPA program including software solutions.
· Duties include, but are not limited to, monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of timelines, and establishing CAPA files.
· Assist/Interface with CAPA owners on CAPA Investigations, Action Plans, and Verification/Validation Activities to drive timely completion of CAPA activities.
· Monitor the suitability and effectiveness of the CAPA system. Identify appropriate metrics and trend CAPA metrics and present defined reports at specified intervals to CAPA Committee and Management Review.
· Maintain and revise applicable quality systems interfacing with CAPA.
· Serve as a resident expert in CAPA regulatory/compliance and coach/mentor employees. Coordinate training for users of CAPA system and develop assorted training materials. Conduct training on root cause investigation and problem-solving techniques.
· Serve as the resident expert for the Health Hazard Evaluation program and train team members on the process that aligns with regulatory requirements.
· Lead and maintain the HHE and Field Action programs.
· Communicates with appropriate regulatory agencies on field action activities and monitor progress until field action closure.
· Perform various activities including support of internal audit program, document control, and post market activities, and regulatory inspections, and notified body audits.
· Participate in audit response activities, including preparation of corrective action plans
and closure of audit findings.
· Monitor regulatory changes and assess their impact on quality systems and procedures.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
· Familiar with aspects and elements of quality systems, including but not limited to, CAPA, management responsibility, product realization and measurement, analysis and improvement process. · Knowledge of all aspects of modern quality control/assurance techniques such as, corrective/preventative action plans, and root cause analysis. · Detail oriented with excellent time management and organization skills · Familiarity with computer usage and application such as (Microsoft Applications such as: PowerPoint, Excel, etc.) · Reliable and capable of working with minimal supervision to manage assigned tasks and follow up activities. · Innovative with the ability to make sound suggestions for improvement. · Possess effective communication skills both oral and written. · Highly compliance oriented to firmly adhere to principles of regulation and standards. · Must possess strong communication skills for Interactions with internal and external customers.
Education/Experience Requirements
· Bachelor’s degree in a technical discipline or an alternative Bachelor’s degree program with certification in a Quality discipline (e.g. CQE, CQA, etc) · Medical Device regulations experience preferred. · 3+ years of experience or equivalent combination of education and experience in medical device, or pharmaceutical field.
Travel Requirements
The role will require occasional travel up to 10%
Related keywords
QMSCAPARoot Cause AnalysisHHEField ActionMedical DevicePharmaceuticalCQECQARegulatory ComplianceInternal AuditPost Market ActivitiesNotified Body AuditsQuality AssuranceQuality Control
Highridge is committed to partnering with surgeons to drive innovation, with a strong portfolio including solutions for complex spine, motion preservation, and minimally invasive surgery.
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Offices: 10225 Westmoor Dr, Westminster, Colorado 80021, US · 7437 Polk Lane #100, Olive Branch, MS 38654, US
How much do Manufacturing jobs in Westminster, CO pay?
Based on 149 listings with disclosed salaries, most manufacturing jobs in Westminster, CO pay between $60k–$165k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in Westminster, CO right now?
There are currently 156 open manufacturing positions in Westminster, CO listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Westminster, CO?
Companies currently hiring include CesiumAstro, BAE Systems, Inc., Ball Corporation, Highridge Medical, Cintas, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Westminster, CO?
Yes — 31 of the 156 open manufacturing positions offer remote or hybrid work (5 remote, 26 hybrid).
How do I apply for Manufacturing jobs in Westminster, CO?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.