Supplier Quality Manager is responsible for all aspects of the Diagnostic Systems supplier quality management including quality management of the OEM instruments and consumable materials.
This role will oversee supplier management activities at all DS sites and will be responsible for development and implementation of the DS-Wide supplier management program.
The role will have direct reports in Sparks, MD and will establish indirect oversight over all DS facilities and supplier management activities performed at DS manufacturing plants World-Wide.
An individual in this position will have the responsibility of development and execution of the supplier management quality strategy and plan, development and execution of the supplier evaluation, assessment and audit schedules, ensuring training and availability of supplier auditors for DS Business unit.
The supplier management organization will also be responsible for complaint investigation and trending activities for OEM instruments and consumables.
Supplier Quality Manager will report directly to Vice President of Quality Management.
Key Responsibilities for this Role:
* Develop and execute quality strategy for supplier management activities and establish goals and metrics for Category III and II suppliers.
* Manage and ensure timely and effective customer complaint closure for OEM instruments and consumables.
* Establish strong links with OEM and key supplier organizations and build a culture of continuous improvement with key DS suppliers.
* Lead, develop, engage and mentor quality organization responsible for supplier management under direct supervision and across DS manufacturing plants.
* Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
* Establish quality agreements with key DS suppliers.
* Proactively manage quality of the OEM, component and subassembly suppliers.
* Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE for supplier management organization.
* Maintain quality management responsibilities for SMIS database and serve as the DS representative on the corporate supplier management network.
Key Qualifications and Attributes:
* Supplier Quality Manager should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class II and III manufacturing and purchasing controls. An In-Vitro-Diagnostic Knowledge is highly desired.
* An individual in this role must have excellent leadership, communication, organization and project management skills.
* Strong knowledge of supplier management practices is required.
* Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa and others.
* A minimum of 7 years of quality assurance or relevant experience. A minimum of 5 years of quality leadership or relevant experience. Experience should be in the Medical Device or Diagnostic industry.
* Bachelor of Science in Engineering, Science, or other technical discipline.
* The ability to make timely critical decisions regarding product quality and/or quality system compliance.
* The ability to effectively lead teams and influence.
* An expert understanding of quality engineering sciences.
* A thorough understanding of 21 CFR §820, ISO 13485, and ISO 14971.
* The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
* The ability to assess and articulate risk when evaluating a situation.
* The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).
* The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.
*Job:* Quality
*Primary Location:* United States
*Shift:* First Shift / Day Job
*Req ID:* QUA101KL