Top 17 quality specialist Jobs in orem ut

Senior Clinical Post Market Specialist
Merit Medical Systems Inc. —South Jordan, UT
- Full-time
- Nursing
- RN License
- Word processing
- Health savings account
- Paid holidays
12d
Quality Coordinator II - Document Control Specialist
Ryder —Provo, UT
- From $22 an hour
- Urgently hiring
- Microsoft Word
- Mid-level
- 3 years
- Paid training
- Health insurance
Quality Assurance Specialist
Aspen Co-Pak LLC —Spanish Fork, UT
- Mid-level
- Office
- High school diploma or GED
Quick Apply
Food Safety Specialist
SENSAPURE INC —Lehi, UT
- $22 - $25 an hour
- Full-time
- Inventory management
- Mid-level
- High school diploma or GED
Quick Apply
Trading Card Assessment Specialist
Card Conduit LLC —Sandy, UT
- $22 an hour
- 8 hour shift
- Computer literacy
- High school diploma or GED
- Quality control
- Paid holidays
- Health insurance
Quick Apply
7d
Sourcing and Quality Specialist / Project Manager - Manage projects in US and China
Canyonwall, LLC —Springville, UT
- Part-time
- Mid-level
- Office
- Team management
Quick Apply
Quality Control Specialist
Route 92 Medical Inc —West Jordan, UT
- $24 - $28 an hour
- Full-time
- Mid-level
- 3 years
- High school diploma or GED
- Paid parental leave
- Health savings account
Quick Apply
Quality Assurance Specialist
Route 92 Medical Inc —West Jordan, UT
- $24 - $28 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
- Paid parental leave
- Health savings account
Quick Apply
Field Professional
STRATA —Sandy, UT
- Weekends as needed
- Construction site
- Mid-level
- 1 year
- Paid parental leave
- Paid holidays
Quick Apply
Sr. Commissioning Specialist
Southland Industries Inc. —Eagle Mountain, UT
- Microsoft Excel
- Microsoft Outlook
- Construction site
- Paid parental leave
- AD&D insurance
Electrical Commissioning Specialist
Revolution Technologies, LLC —United States
- $70 - $80 an hour
- Full-time
- Background check
- Up to 50% travel
- 5 years
- Health savings account
- Health insurance
Quick Apply
1d

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quality specialist jobs near orem ut

Senior Clinical Post Market Specialist

Merit Medical Systems Inc. -
South Jordan, UT

Apply Now

Job Details

Full-time
12 days ago

Benefits

Health savings account
Paid holidays
Health insurance
Dental insurance
401(k)

Qualifications

Customer communication
Content creation for technical audiences
Technical documentation
ISO standards
Word processing
Safety regulations
Spreadsheets
GMP
Trend analysis
Data summary reports
Quality risk management
Data management
Biomedical regulatory compliance
Regulatory compliance analysis
Technical writing within technology
FDA regulations
Database software proficiency

Full Job Description

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

WORK SHIFT

DAY (United States of America)

SUMMARY OF DUTIES

Performs diversified responsibilities in the Post Market Surveillance department. Works with internal and external customers to ensure proper handling and documentation of post market surveillance data.

ESSENTIAL FUNCTIONS PERFORMED

Ensure compliance with the following quality management sub-systems:

Provides clinical subject matter expertise to Health Hazard Evaluation (HHE) reports, ensures selected hazards and harms in HHE are accurate and makes overall HHE process improvement recommendations
Executes assigned Post Market Surveillance (PMS) documentation processes such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR)
Assists or executes any assigned Field Correction Action (FCA) and Recalls and makes process improvement recommendations as requested
Reviews in process and previously established Risk Management File contents for appropriate harms relative to identified device hazards
Documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations
Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities.
Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility, specifically for appropriately evaluating returned medical device products for compliance to stated specifications and ascertaining any respective risks to patient safety.
Assists in maintaining and establishing Post Market Surveillance Documentation, HHE and Field Corrective Action and Recall systems focused on specific reporting timeliness and consistent, compliant process execution. Expected to maintain PMS and FCA reporting compliance to all applicable regulation time requirements.
Maintains appropriate records for PMS, HHE and FCA reporting systems as defined in relevant procedures.
Establishes and maintains awareness of relevant regulations and standards to ensure the company's post-market surveillance practices align with industry requirements.
Participates in and, when requested, leads timely trend review of serious and non-serious events and reports to notified bodies based on inquiries associated with EU-MDR submissions and/or submitted PMS documentation.
Coordinates and interacts with various levels of management, international regulatory affairs/quality assurance, and global regulatory bodies on the adverse event reporting, customer complaints and Global PMS requirements and deliverables.
Leads timely, responsive, and evidence-based communication to regulatory authorities, notified bodies, customers, and external entities upon request.
Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as directed.
Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies.
Performs other duties, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting - Not to exceed 50 lbs. - local practice may apply.

Writing

Sitting

Standing

Bending

Visual acuity

Color perception

Depth perception

Reading

Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

Possess a minimum of a registered nursing (RN) or licensed nurse practitioner (LNP) or equivalent education and experience to support regulatory determinations of potential clinical harms in support of HHE related decision making.

At least eight (8) years of work-related experience in the medical device industry

Knowledge of U.S. FDA regulations (21 CFR 803, 806, 820), the Medical Devices Directive (93/42/EEC, as amended), the European Medical Device Regulation 2017/745 (MDR), ISO 13485 Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP

Knowledge of ISO 14971 Risk Management related activities and requirements.

Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows. Presents numerical data effectively. Attention to detail without losing site of the big picture.

PREFERRED QUALIFICATIONS

Post graduate diploma / master’s degree in quality management.
Familiarity with process improvement and use of Lean and Six-Sigma resources and tools.
American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)
Regulatory Affairs Certification – RAC (Global).

COMPETENCIES

Leadership and coaching.
Oral and written communication
Interpersonal skills
Conflict management
Problem solving
Decision making

COMMENTS

Infectious Control Risk Category III:

The risk category explains whether employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

As an eligible Merit employee, you can expect the following:

Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

Medical/Dental & Other Insurances (eligible the first of month after 30 days)

Low Cost Onsite Medical Clinic

Two (2) Onsite Cafeterias

Employee Garden | Gardening Classes

3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers .

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

Apply Now

Refine Your Search

quality specialist jobs in orem ut

Senior Clinical Post Market Specialist

Quality Coordinator II - Document Control Specialist

Quality Assurance Specialist

Food Safety Specialist

Trading Card Assessment Specialist

Sourcing and Quality Specialist / Project Manager - Manage projects in US and China

Quality Control Specialist

Quality Assurance Specialist

Field Professional

Sr. Commissioning Specialist

Electrical Commissioning Specialist

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