Senior Quality Engineer
To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and quality objectives.
Key Responsibilities:
* Assure compliance to applicable regulations.
* Lead quality activities such as audits, procedure development, documentation review and define changes to controlled documents.
* Provide QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.
Requirements:
* 5 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite.
* Auditor certification from an industry recognized organization is beneficial.
* Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO
* Experience in preparation for notified body and FDA inspections.
Essential Skills / Experience:
* Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
* Excellent interpersonal skills and ability to work with people to achieve results.
* Excellent written and communication skills, fluency in English.
* Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both company and their customers.
Additional Requirements:
* Proficiency in MS office products.
* Good business acumen.