Quality Systems Specialist

4 weeks ago

Logan, United States ELITechGroup Inc. Full time
Job DescriptionJob DescriptionSummary

Supports the creation, development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records.

Essential Duties and Responsibilities
  • Quality Planning
  • Writes and executes quality plans.
  • Establishes Quality Control points that are used to monitor progress and achievement of quality plans.
  • Integral part of the implementation and continued support team for an electronic Quality Management System (eQMS).
  • Quality Management System Support
  • Corrective and Preventive Action (CAPA)
    • Performs investigative research and trend analysis of complaints, discrepant material, process control variations, and other quality-related issues to understand and identify areas for improvement.
    • Compiles information and uses various improvement tools (Lean, Six Sigma, etc) and statistical techniques to assess and determine root cause of problems.
    • Initiates corrective or preventive action and solicits approval through the CAPA process for all proposed actions.
    • Implements corrective or preventive action through formal change control.
    • Compiles, analyzes, and tracks the implementation of CAPA plans and reports results to key stakeholders.
    • Assesses the effectiveness of all corrective and preventive actions.
  • Nonconforming Product
    • Oversees and champions the routine effort to identify, track, control, and quarantine all nonconforming products.
    • Conducts reviews to determine the source and root cause of nonconforming products to prevent reoccurrence.
    • Conducts risk analysis to ensure proposed product disposition is appropriate and acceptable.
    • Reviews and approves all NCR dispositions.
  • Complaint Handling
    • Investigate all complaints.
    • Determines if complaints require specific action including but not limited to product recall, adverse event reporting, regulatory notification, etc.
    • Conducts trend analysis to identify reoccurring issues that should be addressed through formal corrective or preventive action or change control.
  • Internal Audits / External Audits
    • Conducts internal audits according to the internal audit schedule or as assigned.
    • Prepares audit checklists, conducts interviews, and records observations, opportunities for improvement, and audit nonconformities in a formal Audit Report.
    • Follows up and clears down all audit nonconformities in future internal audits.
    • Participates in External Audits as assigned.
  • Quality Training
    • Consistently provides quality training to individuals throughout the company.
    • Provides role model behavior regarding adherence to process and procedure.
  • Process Control and Quality Improvement
    • Reviews quality and operational processes including manufacturing and QC to ensure processes are adequately controlled.
    • Prepares appropriate quality control points throughout the facility to provide evidence that processes are in control.
    • Works with department supervisors to identify opportunities for improvement.
    • Implements improvements that reduce variation and improve overall quality.
  • Document Control and Record Control
    • Supports the document control team as assigned.
    • Establishes and maintains records of all actions according to established processes and procedures.
  • Other
    • Participates and supports the control of all inspection, measuring, and test equipment.
    • Helps to monitor the progress and implementation of quality objectives.
    • Regularly tracks and updates key performance indicators, which are used to assess the overall effectiveness of the Quality Management System.
    • Assists with related special projects, as required.
Qualifications
  • Bachelor's degree (B.S.) degree in Life Science or Engineering discipline plus three years quality related experience in the manufacturing industry; or five years of direct Quality or Regulatory related experience. Practical experience/training in quality planning, Corrective/preventive actions systems, quality auditing, root cause analysis, and problem-solving are highly desirable. Experience in implementing eQMS software, or years of experience using eQMS software is highly preferred.
  • Good knowledge and skills in the use of advanced personal computer productivity programs for wordprocessing, spreadsheets, database manipulation, cloud-based software, and flow
  • Demonstrates working knowledge of ISO13485 quality system and/or FDA 21 CFR 820 quality
  • This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job
Work Environment

While performing the duties of this job, the employee is not exposed to environmental conditions. The noise level in the work environment is usually moderate.



Job Posted by ApplicantPro

  • Quality Systems Specialist

    10 hours ago

    Logan, United States ELITechGroup Full time

    Summary Supports the creation, development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records. Essential Duties and Responsibilities Quality Planning Writes and executes quality plans. Establishes Quality Control points that are used to monitor...

  • Quality Systems Specialist

    3 weeks ago

    Logan, United States ELITechGroup Full time

    Summary Supports the creation, development, management, maintenance, control, and overall improvement of the Quality Management System and corresponding processes, procedures, work instructions, and records. Essential Duties and Responsibilities Quality Planning Writes and executes quality plans. Establishes Quality Control points that are used to monitor...

  • IT Specialist

    7 days ago

    Logan, United States The Family Place Full time

    The Family Place Utah is a 501(c)3 nonprofit organization striving to achieve its mission of Strengthening Families and Protecting Children in Cache, Rich, and Franklin counties through therapy, education, and 24-hour Kid's Place care and shelter services. The IT (Information Technology) Specialist is a full-time position that maintains responsibility for...

  • Quality Assurance Manager

    2 days ago

    Logan, United States Malouf Companies Full time

    Position SummaryMalouf is looking for an experienced Quality Assurance Manager to be responsible for overseeing our global quality activities and initiatives. The candidate will have significant support from management but must have experience with traditional quality related activities such as developing, implementing, and maintaining quality systems....

  • Parts Support Specialist

    1 week ago

    Logan, United States Miele Group Full time

    ** Position Description** **Parts Support Specialist** City **Logan** State **Utah** **Its a good time to be with Miele!** **Job Purpose** To provide assistance to Miele Service Partners, Customers and Consumers in the selection and ordering of parts or accessories. Delivering information and resolving issues in an accurate and timely manner. Must work well...

  • Nursing Director of Quality and Risk Management

    2 weeks ago

    Logan, UT, United States SCA Health Full time

    Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality outcomes...

  • Information System Security Engineer

    3 days ago

    Logan, United States Space Dynamics Laboratory Full time

    Job ID: 17909 The Space Dynamics Laboratory (SDL) is seeking a highly experienced Information Assurance (IA) Systems Security Engineer (ISSE) to join our dynamic team. In this role, you will collaborate closely with our IA office and work alongside a full-stack engineering team in both operational and development environments. Your expertise will be...

  • Information Systems Security Manager

    3 days ago

    Logan, United States Space Dynamics Laboratory Full time

    Job DescriptionJob DescriptionJob ID: 18508The Space Dynamics Laboratory (SDL) is seeking an experienced Information Systems Security Manager (ISSM) to manage information assurance efforts for corporate, cloud, and collateral information systems at our Logan, UT site.At SDL, we take pride in and highly value our employees. SDL offers competitive salaries and...

  • Information Systems Security Manager

    2 days ago

    Logan, United States Space Dynamics Laboratory Full time

    Job ID: 18508 The Space Dynamics Laboratory (SDL) is seeking an experienced Information Systems Security Manager (ISSM) to manage information assurance efforts for corporate, cloud, and collateral information systems at our Logan, UT site. At SDL, we take pride in and highly value our employees. SDL offers competitive salaries and fantastic benefits,...

  • Information Systems Security Manager

    21 hours ago

    Logan, United States Space Dynamics Laboratory Full time

    Job ID: 18508 The Space Dynamics Laboratory (SDL) is seeking an experienced Information Systems Security Manager (ISSM) to manage information assurance efforts for corporate, cloud, and collateral information systems at our Logan, UT site. At SDL, we take pride in and highly value our employees. SDL offers competitive salaries and fantastic benefits,...

  • Senior Program Manager

    3 days ago

    Logan, United States Space Dynamics Laboratory Full time

    Job DescriptionJob DescriptionJob ID 14960BWHO WE AREWith over 60 years of mission success, SDL is focused on serving our customers, enhancing our multi-domain capabilities, and developing leading-edge technologies. We are looking for a leader to enhance our Strategic and Military Space (SMS) Division team. The SMS Division at SDL supports the Department of...

  • Irrigation Specialist

    3 weeks ago

    Logan, United States Logan City Full time

    Job DescriptionJob DescriptionSalary: $23.59 - $25.67 HourlyJob Type: Full-timeDepartment: Parks & RecreationLocation: Logan, UtahFLSA Status: Non-exemptAppointed Position: NoJob Number: 24-15Closing Date: Until FilledDescription:Under general supervision, performs a variety of skilled and semi-skilled general plumbing and sprinkler maintenance and repair...

  • On Call Support Specialist/Receptionist

    7 days ago

    Logan, United States BEAR RIVER MENTAL HEALTH SERVICES, INC. Full time

    This is an On Call position for coverage, as needed. Primary Duties: Greet clients and process them through check-in, including payment collection, client outcome survey processing, receipting, and therapist notification of client arrival. In the case of admit appointments, complete automated client admit procedures. Answer, screen, and route incoming...

  • Director Nursing- Northern Utah Surgery Center

    3 weeks ago

    Logan, United States Surgery Care Affiliates Full time

    Overview Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of...

  • Director Nursing- Northern Utah Surgery Center

    2 weeks ago

    Logan, United States SCA Health Full time

    Overview:Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • Director Nursing- Northern Utah Surgery Center

    2 weeks ago

    Logan, United States SCA Health Full time

    Overview:Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • Information System Security Engineer

    2 days ago

    North Logan, United States Space Dynamics Laboratory Full time

    Job ID: 17909 The Space Dynamics Laboratory (SDL) is seeking a highly experienced Information Assurance (IA) Systems Security Engineer (ISSE) to join our dynamic team. In this role, you will collaborate closely with our IA office and work alongside a full-stack engineering team in both operational and development environments. Your expertise will be...

  • Director Nursing- Northern Utah Surgery Center

    3 weeks ago

    Logan, United States Surgical Care Affiliates Full time

    Overview Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • Registered Nurse Operating Room, Pool

    2 weeks ago

    Logan, United States SCA Health Full time

    Overview:Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • Dental Billing/Receptionist

    1 month ago

    Logan, United States Logan Mingo Area Mental Full time

    Job DescriptionJob DescriptionThis is a full time position located at MLIH's Dental clinic at our 3 Mile location in Logan, WV.We are looking to hire a personable dental receptionist to ensure that dental patients’ appointments are appropriately scheduled, rescheduled, or canceled, depending on the needs of the patients. The dental receptionist’s...