Site Quality Lead - Telford, PA

Site Quality Lead -

Telford, PA Business Unit:

 Draeger Medical Systems, Inc.,

Job-ID:

 1233

Location:

Telford

Function:

 Quality

Work Location:

 On-Site

Employment Type:

 Permanent The Job Responsibilities 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. Your Qualifications 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. Dräger Benefits At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include: Medical, dental, and vision insurance Life, short- and long-term disability coverage 401(k) with company match Over 4 weeks of paid time off, plus holidays and parental leave Flexible spending accounts and employee assistance program Select locations also offer free parking, an on-site gym, cafeteria, and game room. Talk to your Draeger recruiter to learn more! Who we are We're hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle "Technology for Life". Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario. Draeger is an Equal Opportunity Employer. Interested? Please, apply directly through our career portal.

We look forward to receiving your application.