Omnicell, Inc. Senior Director, Global Supply Chain Quality in Milpitas, California

Senior Director, Global Supply Chain Quality

Description

Senior Director, Global Supply Chain Quality

The role will manage the Supply Chain Quality functions of all of Omnicell’s Global Businesses. This person is accountable for the quality from our suppliers, O DMs, and contract manufacturers. This role will coordinate objectives and strategies with other leaders of the company, so high-level objectives are met.

This function will own the strategies for ensuring quality and industry best practices are integrated upstream within the supply chain and product development functions. This individual will direct the execution and performance of the company's Supplier Qualification and Performance Program for top suppliers and OEM partners and responsible to overall Supplier Quality Management activities. This function will also be responsible for partnering with Engineering and Program Management to implement Design Assurance activities within the Product Development Process (PDP).

Responsibilities:

  • Quality Manager for Omnicell’s Global Supply Chain. Have overall responsibility for ensuring our products (Global Supply chain) exceed Omnicell and our customer’s quality requirements.

  • Represent the voice of the customer and quality ensuring the right balance of quality and cost are achieved.

  • Develop and implement the business quality strategy aligned with Omnicell’s strategic priorities.

  • Define and execute strategy for the qualification, performance, and development of new and existing suppliers through conducting Quarterly Business Reviews (QBR), metric data analysis and supplier assessments. With purchasing, define and implement supplier strategy across over 150 active suppliers and over $65 million in annual spend.

  • Manage global quality processes and procedures. Drive alignment across global factory network. Ensure best practice sharing between sites.

  • Form strong partnerships with purchasing, hardware engineering, manufacturing engineering, and business development so that high-level objectives are met related to strategic partnerships, NPI, and supplier performance.

  • Accountable for defining and driving Omnicell quality policies and expectations with supplier partners and ensuring requirements are consistently met with regard to product specifications, industry best practices, and implementation of ISO standards. Serve as technical resource for process improvements projects internally and at the supplier pertaining to Omnicell designed product.

  • Manage and facilitate the root cause & corrective actions with suppliers and OEM partners. Validate and track supplier issues. Support root cause analysis through facilitating Supplier Corrective Actions (SCARS) and the use of quality methodologies such as 8D, CAPA, pareto charts, etc.

  • Develop, monitor and report on Key Performance Indicators (KPIs) and assist suppliers in the formation of statistical sampling plans, inspection methodology, and procedures using 6 sigma approach. Provide technical consultation on statistically valid sampling plans for inspection and acceptance criteria.

  • Ensure product regulatory compliance is met for Omnicell and OEM product for domestic and international markets Omnicell serves. Engage with OEM partners to obtain required certification reports and/or conduct certification testing to meet market regulatory requirements. Support internal product regulatory projects as required.

  • Cross-functional participation in production quality processes, supplier survey/ audit responsibilities, and new product introduction. Assist production & quality in resolving internal and external audit findings and observations, non-conformance reports, and corrective actions related to supplier’s performance.

  • Lead/facilitate review of discrepant materials identified and provide direction as to their corrective action and disposition. Provide support to suppliers regarding use of the Agile PLM database.

Required Knowledge and Skills:

  • Demonstrable knowledge of Quality in a high tech manufacturing environment with medical device and other products which include Hardware and Software complexities.

  • Experience leading a global team

  • Experience leading change in a matrix organization

  • Demonstrable knowledge of Quality processes and tools.

  • Developing and delivering training packages for various quality functions to suppliers and employees

  • Specific training and demonstrated success in applying quality problem-solving methods such as fishbone diagrams, FMEA, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc.

  • Demonstrable knowledge and experience of ISO 9001, ISO 13485, and FDA QSR

  • Strong leadership capabilities.

  • Ability to work cross-functionally

Basic Qualifications:

  • Bachelor’s degree in Engineering

  • 10+ years of experience with Quality function, ideally quality supplier management

  • 5+ years of experience in Industrial/manufacturing engineering, supplier management, Manufacturing

Preferred Qualifications:

  • MS engineering degree preferred.

Work Conditions:

  • Office Environment

  • Travel of approximately 30% or more globally to meet with other Omnicell business units, suppliers and contract manufacturers.

  • Visits to customers and installation sites are on an as-needed basis.

  • Global role with personnel located across the US and International

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.