Regulatory Affairs and Quality Assurance Associate (Medical Device)

Harrisburg, PA, US • Posted 14 hours ago • Updated 48 minutes ago

Full Time

Part Time

On-site

Fitment

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Job Details

Skills

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

Summary

About the job

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

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.

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 - 8004-7008-1772720095
Posted 14 hours ago

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