Compliance Engineer, Quality Systems

Position Summary

Compliance Engineer I is an entry-level role focused on supporting the company’s regulatory and quality compliance initiatives. Under guidance of the Quality Manager and other Teleflex global resources, this position supports adherence to the applicable regulations and standards. Improves and maintains the quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS). The role will also involve multi-site collaboration with Teleflex Medical offices in addition to other departments.

Principal Responsibilities

1.    Assist in maintaining compliance with ISO 13485, FDA, and MDR requirements by supporting document control, training, and risk management activities.
2.    Help in implementing and maintaining QMS processes related to medical device compliance, including document control, corrective actions, and recordkeeping.
3.    Assist with the preparation and execution of internal audits to assess compliance with applicable regulations and standards.
4.    Support risk management activities (e.g., FMEA) and ensure that risk documentation aligns with regulatory requirements.
5.    Assist with ensuring accurate, complete, and compliant documentation in alignment with regulatory standards.
6.    Participate in training sessions related to compliance and quality and provide support in educating staff on regulatory requirements.
7.    Assists in identifying appropriate standards for development and remediation of design history files/technical files.
8.    Assists in developing communications to regulatory bodies, submissions, providing written responses, notifications, and updates, attending agency meetings.
9.    Assists in performing gap analysis on a revised standard and execute deliverables to ensure continuous compliance to applicable current standards and regulations.
10.    Assists in solving problems in quality, including management of non-conformances, deviations and CAPA.
11.    Ability to offer detailed, practical, and compliant solutions to identified quality system and regulatory gaps.
12.    Ensures the promotion of awareness of applicable regulatory and QMS requirements throughout the organization.
 

Education / Experience Requirements

•    Bachelor of Science degree in related field.
•    0-2 years experience of working in the medical device industry.
•    Knowledge of MS Office.
•    Ability to prioritize and work under set deadlines.
•    Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality. 
•    Must possess excellent communication skills, both verbal & written 
•    Ability to work in a fast paced, team-oriented work environment.
 

Specialized Skills / Other Requirements