Senior Quality Engineer
Provides 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.
Qualifications:
* 5 years minimum QA, Quality System, or regulatory experience in the medical industry.
* Auditor certification from an industry-recognized organization is beneficial.
* Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO.
* 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.
* Experience in preparation for notified body and FDA inspections.
* Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both company and their customers.
* Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
* Proficiency in MS Office products.
* Good business acumen.