Regulatory Affairs and Quality Assurance Associate (Medical Device)

Denver, CO, US • Posted 7 hours ago • Updated 11 minutes ago

Full Time

Part Time

On-site

Fitment

Dice Job Match Score™

✨ Finding the perfect fit...

Job Details

Skills

Regulatory Affairs
Continuous Improvement
ISO 13485
Technical Writing
Auditing
Training
Risk Management
Document Management
Inventory
Reporting
Management
Promotions
Quality Management
System Requirements
Quality Assurance
Quality Control
Problem Solving
Conflict Resolution
Customer Engagement
Medical Devices
Analytical Skill
Communication

Summary

Roles & Responsibilities

1. Implementation and continuous improvement of the Medical Device Quality

2. Management Systems and associated CE requirements in order to meet customer

3. and regulatory requirements
4. Preparation, implementation, and Maintenance of Manual, policies, work instructions as per ISO 13485 5. Preparation, implementation, and Maintenance of Technical documentation (MDR) wrt applicable requirements

6. Review and formal approval of technical reports.

7. Facilitate internal/external audits and evaluate audit findings and implement

8. appropriate corrective actions

9. Investigate customer complaints and non-conformance issues

10. Analyse data to identify areas for improvement in the quality system

11. Identify training needs and organize training interventions to meet quality standards

12. Monitor risk management activities

13. Responsible for document management systems

14. Managing the Inventory & Batch Verifications
15. Management Representative: responsibilities shall be -

a. ensuring that processes needed for the quality management system are documented;

b. reporting to top management on the effectiveness of the quality management system and any need for improvement;

c. ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

Experience/Knowledge/Technical Skills Required:

1. Around 2 to 5 years of experience in implementation in the QA domain preferably with some experience in working in the Medical Devices industry

2. Internal/Lead Auditor of Quality Management Systems

3. Knowledge and application skills of QC/Problem solving tools

4. Good computer skills
5. Knowledge of relevant regulatory/CE requirements for medical devices will be preferred 6. Analytical and structured working style, attention to details

7. Ability to work as part of a team

8. Good verbal and written communication skills

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90737436
Position Id: OOJ - 8048-7052-1773149483
Posted 7 hours ago

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Production Quality Engineer

Thornton, Colorado

•

Today

Air Squared Manufacturing Inc Description: Company: Air Squared Title of Position: Production Quality Engineer Position Type: Full time; Exempt Air Squared Manufacturing, Inc. is an OEM manufacturer of scroll type compressors, vacuum pumps and expanders for the medical, aerospace, fuel cell and power generation industries. Air Squared offers exciting career opportunities working on projects including NASA MOXIE, Leading Electric and Autonomous Vehicle OEM, DOE Clean Energy initiatives rangin

Full-time

USD 75,000.00 - 100,000.00 per year

Staff Software Embedded Engineer - Manufacturing Software (Medical Devices)

No location provided

•

13d ago

Position Title: Staff Software Embedded Engineer - Manufacturing Software (Medical Devices) - Cybersecurity Focus Location: Remote Duration: 6+ Month Contract Job Description: Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or a related field with 10+ years of relevant industry experience, OR Master's degree in a related field with 8+ years of experience. Minimum 2+ years with a security-focused role or equivalent hands-on experience implementing secure s

Easy Apply

Contract

Senior Manager, Supplier Quality (Contract Manufac

Lakewood, Colorado

•

Today

Location: Lakewood, CO Salary: $160,400.00 USD Annually - $200,600.00 USD Annually Description: Our client is currently seeking a Senior Manager, Supplier Quality (Contract Manufacturing) Job Title Senior Manager, Supplier Quality (Contract Manufacturing) Job Location Lakewood, Colorado (open to candidates willing to relocate) Job Overview The Senior Manager, Supplier Quality (Contract Manufacturing) leads the external manufacturing Supplier Quality Engineering (SQE) team and oversees da

Contract

USD 160,400.00 - 200,600.00 per year

Software Quality Analyst

Lakewood, Colorado

•

Today

Location: Lakewood, CO Salary: $85,000.00 USD Annually - $105,000.00 USD Annually Description: Title: QA Engineer Location: Lakewood, CO Hybrid: Yes Employment Type: Full-Time Contact: Ryan Griffin: About the Role We are seeking a detail-oriented Software Quality Analyst to support software validation across our Quality Management System (QMS) and Product Lifecycle Management (PLM) processes. In this role, you will execute validation testing, develop documentation, and ensure our software re

Contract

USD 85,000.00 - 105,000.00 per year

Search all similar jobs