**Quality Assurance Leader Role Overview**
We are seeking a Quality Assurance Leader to join our team. As a Senior Quality Engineer, you will be responsible for ensuring the quality of our products and processes.
**Key Responsibilities:**
* Document Control: Manage document control to ensure consistent and compliant processing.
* Representation in Meetings: Represent quality in R&D meetings, providing advice and documentation reviews.
* Risk Management: Participate in risk management to ensure all risks are mitigated per ISO standards.
* Technical Operations Support: Support technical operations to ensure high-quality product manufacturing.
* Metric Preparation: Prepare quality system metrics for management review.
* Customer Complaint Resolution: Address customer complaints ensuring compliance with regulations.
**Requirements and Qualifications:**
To succeed as a Quality Assurance Leader, you must have:
* Bachelor's Degree: A Bachelor's degree in Science or Engineering.
* Experience: Minimum of 5 years experience in quality engineering or regulatory role, ideally in the medical device industry.
* Skills: Excellent written, interpersonal communication, and presentation skills. Self-starter with the ability to advance company goals with minimal direction. Strong problem-solving, decision-making, and root cause analysis skills.
**What We Offer:
We offer a competitive salary, benefits package including healthcare and pension, opportunities for career advancement and professional development, and more.
**Additional Information:
This job description is not intended to be an exhaustive list of responsibilities. The Quality Assurance Leader may perform other related duties as required.
Skillset: CAPA, ISO, Quality