Quality Supervisor/Engineering

4 weeks ago

Milpitas, United States Omnicell Full time

Overview

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

Location:

  • Milpitas, California

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.)

About Us

Do you want to make a meaningful difference in the quality of healthcare? Omnicell is empowering health systems and pharmacies to radically transform the way they manage medications, so that they can achieve the vision of the Autonomous Pharmacy. Thousands of hospitals, pharmacies, skilled nursing facilities and care homes trust Omnicell to provide continuous innovation. They need us to deliver solutions to meet the ever-evolving challenges of the healthcare landscape. We encourage creative problem solving and outside-of-the-box thinking that only a diverse, well-rounded workforce can bring.

Join us as we build on our powerful combination of advanced automation, predictive intelligence, and expert services to create a safer future for patients - one where medication errors are a thing of the past. You'll be joining an organization whose culture encourages individual development, rewards intellectual curiosity, and embraces an inclusive environment. Join our growing company and help shape the future at Omnicell.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

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.

Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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