Sr. Quality Engineer

· Ability to work independently, but equally in a team environment

· Strong written and very communication skills and attention to detail

· Self-starting, detailed oriented, quick learner, creative and analytical

· Capable of understanding and analyzing complex engineering problems

· Demonstrated leadership, and ability to solve problems and communicate issues

· Understanding of documentation system and management

· Preferable knowledge of Quality System Requirements (QSR), ISO 13485 and CE regulations and compliance thereof.

· Experience in an FDA regulated environment desirable

· Microsoft Office knowledge, including Word, Excel. Experience with Vantage ERP system is a plus. Agile Product Lifecycle Management System is required

· Ability to communicate effectively with all levels of the organization

· Ability to prioritize multiple projects

· Ability to resolve conflicting interests and obtain cooperation

· Additional duties as assigned

· Manages and enhances QMS procedures and policies to ensure compliance. Partners with appropriate stakeholders to define, recommend and implement QMS process improvements.

· Leads internal QMS and supplier audits as needed for compliance.

· Manages Health Hazard Evaluations (HHE) with cross functional team members.

· Facilitates CAPAs as needed to ensure compliance along with timeliness of completion. Leads product complaint investigations as needed and drive to closure related to quality/compliance issues in a timely manner by working with various functions including but not limited to the Quality Control Lab, Quality Engineers, and Compliance team members to determine root cause(s), evaluate, disclose and appropriately remedy risks and deficiencies . Supports development of key QMS metrics. Provides analysis and reporting for Monthly Trend and Management Review Meetings.

· Provides quality/compliance guidance, along with the review and approval of project documentation to ensure quality and compliance for new product development (NPD)s

· Plans and manages quality/compliance activities, identify road blocks, and strategizes on various compliance paths for new products.

· Supports Sustaining Projects, Special Projects and Project Teams for Risk Management Activities as needed.

· Provides support to Regulatory Affairs and Quality Engineering as needed, including independent reviews in the areas of sterilization, cleaning validations, etc