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Incoming Quality Supervisor/Engineer

Quality Supervisor/Engineer

Full-time, salary position on site in Milpitas, CA reporting to the Manager of Production Quality. The Quality Supervisor/Engineer will oversee the incoming inspection, non-conformance, and final quality acceptance processes. This includes inspection planning coordination, material review board, and process auditing.

Core Responsibilities:

• Provide supervision to employees in their respective areas (Incoming Inspection, Non-Conformance, and Final Inspection).

• Provide guidance for incoming inspection criteria

• Coordinate inspection plan and schedule for first article inspection (FAI).

• Manage the material review board process including defect Pareto and trend analysis.

• Facilitate root cause analysis for non-conformances through brainstorming, use of fishbone diagrams, 8D methodologies, CAPA, and design of experiments, etc.

• Participate in the change control process as needed.

• Manage and maintain the calibration program.

• Manage in-process audit program.

• Present operational and quality metrics related to process audits, MRB, and final inspection.

• Maintain Quality Management System

Additional Responsibilities:

• Support the Quality Department objectives and goals by managing or participating in Quality projects.

• Lead and participate in CAPAs as required.

• Support Supplier Corrective Action closure via verification activities.

• Work cross-functionally with other functional departments.

Required Skills and Knowledge:

• ISO 13485 and/or FDA (CFR 820) Medical Device knowledge.

• Ability to effectively interface and communicate with multiple constituents, including senior management, consultants, suppliers, and employees of all levels.

• Ability to grow and mentor peers and direct reports, and work collaboratively across all organizational levels.

• Change agent who accepts and supports new ideas and processes.

• Strongly demonstrated written and verbal communication skills.

• Ability to consistently balance sense of urgency with diplomacy/empathy.

• Strong time management skills and attention to detail.

• Strongly demonstrated organizational and project management skills.

• Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project).

• Team builder, self-starter, organized, and analytical.

Basic Qualifications:

• Bachelor of Science degree

• Minimum of one (1) year of supervisory experience

• Minimum of three (3) years of experience in manufacturing environment

• Demonstrated success in applying quality problem solving methods such as fishbone diagrams, 5-Why, FMEA, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc.

Preferred Qualifications:

• Experience working with complex electro-mechanical systems

• Experience with broad variety of measurement and quality data analytic techniques

• ISO 13485 and/or FDA (CFR 820) Medical Device knowledge

• ISO 9001:2015 or IATF/TS 16949 experience

• Understanding of AQL levels contained in ANSI standards.

• SAP experience

• Minitab experience

• GD&T knowledge

Work Conditions:

• Office Environment

• May travel up to 10%

Base Compensation: $95,018 to $121,411

(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)

Since 1992, Omnicell has been committed to  transforming pharmacy care  through  outcomes-centric innovation  designed to optimize clinical and business outcomes across all settings of care. We strive to be the healthcare provider’s most trusted partner by our guiding promise of “Outcomes. Defined and Delivered.”  

Our comprehensive portfolio of _ robotics, smart devices, intelligent software, and expert services _ is helping healthcare facilities worldwide _ to improve business and clinical outcomes_ _ as they move closer to the industry vision of the Autonomous Pharmacy. _

Our guiding principles inform everything we do: 

• As Passionate Transformers , we find a better way to innovate relentlessly. 

• Being Mission Driven, we consistently deliver on our promises. 

• Our Entrepreneurial spirit makes the most of EVERY opportunity for innovation. 

• Understanding that Relationships Matter creates synergies that yield the greatest benefits for all.

• In Doing the Right Thing , we lead by example in ALL we do. 

We value creating an inclusive culture and a healthier world through ESG initiatives, Employee Impact Groups, learning, well-being programs, and more. Join us in transforming the pharmacy care delivery model, making patient care safer and smarter for all.

About The Team

Omnicell is dedicated to fostering a diverse and inclusive workplace. We welcome applications from all individuals, valuing a wide range of perspectives and backgrounds. As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at Recruiting@omnicell.com .

At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation. However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations.

Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization's evolving needs and drive our mission forward.

Job Identification: 2197

Job Category: Quality

Posting Date: 05/23/2024, 7:19 PM

Job Schedule: Full time

Locations: Milpitas, CA, United States

Job Level: Supervisor / Manager

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.