Principal Quality Engineer
We are seeking a Principal Quality Engineer to join our team.
The successful candidate will work as part of the Quality and Regulatory Affairs teams, responsible for tasks related to the development and maintenance of quality systems to support the organization.
Key Responsibilities:
* Support the VP of Quality and Regulatory Affairs in developing and maintaining a quality system in compliance with ISO and 21 CFR Part 820.
* Manage document control functions to ensure consistent and compliant processing of all documents.
* Represent the quality function at functional team meetings and provide advice and complete documentation reviews in a timely manner.
* Participate in risk management processes to capture and mitigate risks in accordance with ISO requirements.
* Liaise with technical operations to support device manufacturing, ensuring high-quality product delivery in compliance with procedures and regulations.
* Prepare quality system metrics for management meetings and review.
* Ensure customer complaints are addressed in compliance with regulations and relevant vigilance and reporting requirements.
* Manage and implement the CAPA system, addressing observations in accordance with procedures.
* Maintain computerized system validation in accordance with documented procedures and regulations.
* Schedule internal audits and address non-conformances, observations, and recommendations in a timely manner.
* Support supplier management, ensuring sub-contractors, suppliers, and external parties meet quality system requirements.
* Prepare reports, documents, and specifications to ensure project success.
* Support continuous improvement of quality system processes and the business.
* Complete additional tasks designated by supervisors to support business needs.
Requirements:
* Bachelor's degree in Science or Engineering is a pre-requisite.
* A minimum of eight years experience in quality engineering or regulatory roles, ideally in the medical device industry.
* Excellent written, interpersonal communication, and presentation skills.
* A self-starter who can see and deliver work required to advance company goals with minimal direction.
* Excellent communications skills, summarizing information from different sources, reconstructing arguments, and presenting coherently.
* Solid grasp of team dynamics and ability to participate in teams delivering outstanding results.
* Holds themselves and others accountable for meeting commitments.
* Able to prioritize and focus on critical objectives amidst numerous project tasks and activities.