Quality Manager I
Westlake Village, CA
Req ID 46299BR
Business Title
Quality Manager I
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
The Manager I, Global Supplier Quality Engineering manages the coordination of the Divisional activities related to Supplier performance improvement plans and processes within in the Global Supplier Quality organization. The Manager I is primarily responsible for managing a staff of Supplier Quality Engineers and for establishing and/or enhancing BioScience systems and procedures to ensure that suppliers of materials, components, and services that affect quality division-wide are capable of providing the level of quality required.
•Manages the Divisional Global Supplier Quality Engineering team members, to include coaching and directing reports to establish annual goals and long range plans from a professional growth and business perspective.
•Supports the shared vision and common goals across teams and strong relationships within and outside of Baxter, and effectively manages long-term relationships with external stake holders.
•Responsible for supplier quality planning and launch activities including the identification of Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) based on the supplier capability/performance, their incorporation into applicable Baxter material specifications, supplier FMEA and Control Plans.
•Responsible for developing tier 1 suppliers to achieve and maintain acceptable process capability or performance and control for products supplied to Baxter or have agreed risk plans in place.
•Responsible for developing, measuring and monitoring tier 1 and tier 2 supplier quality metrics to ensure consistent supply of quality raw materials and drive improvement.
•Responsible for implementing, maintaining and improving applicable Division supplier quality procedures.
•Lead efforts in resolving tier 1 supplier quality issues including review of SCARs for appropriateness prior to initiation and ensuring investigations result in timely containment, root cause analysis and appropriate corrective and preventative actions.
•Responsible for alignment of starting and experimental material specifications across multiple suppliers and plants.
•Responsible for implementation of standardized tier 1 supplier quality agreements.
•Supports the integration of supplier quality management systems of new or acquired businesses into the BioScience System.
•Participate on functional project management teams to evaluate and qualify new suppliers/products to achieve business objectives.
•Ensures adherence to the Division Supplier Quality budget.
Job Requirements
Education:
•Minimum of a Bachelor degree in a related field (physical science or engineering); Advanced degree preferred. Special Skills:
•Minimum of 7-8 years experience in an engineering role in a GMP environment preferably in the pharmaceutical or medical device industry.
•3-5 years of management experience.
•Project management skills required; previous experience in the implementation of a quality engineering program preferred.
•Experience related to Supplier Quality Management preferred.
•Knowledge and understanding of Global regulations pertaining to drug and device supplier quality (e.g. 21 CFR, MEDDEV, etc.), international standards to include current issues of ISO 9001, ISO 13485 and ISO 17025 or their replacements and applicable Baxter procedures, specifications and standards.
•Able to manage employees, conduct performance reviews, establish development plans and manage resources.
•Proficient in problem solving through the use of continuous improvement tools. Able to teach and use continuous improvement tools.
•Strong decision maker and risk management skill set required to drive innovative solutions and problem solving analysis and resolution.
•Experience in interpreting regulations and quality systems.
•Demonstrated project management skills; ability to lead multiple tasks/projects within timelines.
•Ability to manage diverse stakeholder interests and expectations.
•Excellent oral and written communication, interpersonal, analytical and presentation skills.
•Must have excellent negotiation skills.
•Experience with data collection and metrics, analysis and reporting.
•ASQ Certified Quality Engineer is very desirable.
•Knowledge of computer systems for word processing, data analysis, and custom databases
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
