Site Quality Lead - Telford, PA

We are looking for a Site Quality Lead for our Telford, PA location.

The Site Quality Lead will provide direction and tactical, hands-on management of the Draeger Medical Systems Inc. (DMSI) Telford Site Quality activities. The candidate will be a hands-on and insightful manager with abilities to ensure compliance, lead internal and external audits, support operations including Service and Repair Center, site calibration, and Innovian Anesthesia. Functional management of quality engineers and specialists supporting site quality activity. Partner with DMSI Andover site as necessary to ensure alignment and harmonization within the DMSI QMS.

Responsibilities:

• Responsible for maintenance of and compliance to DMSI/Telford site quality system processes and procedures to sustain compliance to company procedures, domestic and international regulations, and standards.
• Direct support and management of Product and Supplier Quality resources directly supporting Telford-based operations including but not limited to software design changes, North American Global Service Centers for Medical and for Safety, Safety supplier and product quality, and facilities changes. Hold responsibility of DMSI Software Validation Officer role.
• Partner with operations and shared service management to establish and maintain good manufacturing and compliance practices and foster a strong quality culture.
• Ensures quality records are handled effectively maintaining compliance and traceability
• Maintain Telford calibration program and ensures compliance in alignment with external calibration service partners and internal stakeholders (e.g. Draeger, Inc.)
• Site coordination for the record storage process, including label distribution, database updates, records maintenance.
• Act as site quality lead in terms of external audits, regulators, notified bodies, etc. Act as site management representative and audit facing roles as needed.
• Drive resolution to internal and external issues via use of effective and compliant quality system processes and communication.
• Monitor the performance of the Quality System through site quality metrics and determine notifications/escalations, as appropriate to Executive Management
• Performs other duties as needed and assigned.

• BS degree required. BS in an engineering, medical or scientific discipline preferred. Related education, training and experience will be considered.
• Minimum of 5-7 years of Quality experience in medical device/life science functions commensurate with accountabilities described above.
• Extensive knowledge and understanding of US, European and International medical device regulations, standards, and guidance documents.
• Significant experience working with regulatory agencies (i.e. FDA) and competent authorities or working directly on regulatory agency documentation and communication.
• Demonstrated leadership experience within a product development environment of complex medical products. Experience with software-based capital equipment products preferred.