Cardinal Health WaveMark is a rapidly growing platform that enables hospitals and medical device manufacturers to efficiently manage the inventory and usage of high value medical devices and implantables throughout the supply chain, all the way to the point of use. WaveMark leverages advanced technologies such as RFID, NFC, and mobile, as well as a cloud-based advanced analytics platform.
This position, reporting to the Hardware Director, is responsible for delivering all aspects of the Supplier Operations Quality Assurance, Quality Management System and Compliance functions on an on-going basis in line with the Quality Management System and Quality Policy to ensure that the business’ products and services are fit for purpose and meet customer expectations. Responsible for ensuring that suppliers continue to develop and implement best practice that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements and continue to meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are adhered to. This is a hands-on leadership position that includes direct responsibility for the execution and maintenance of regulatory and contract compliance through process compliance audits, documentation management and verifiable corrective and preventive actions.
- Contribute to the creation and implementation of best practice quality vision, strategy, policies, processes and procedures to aid and improve operational performance.
- Contribute to new business initiatives and projects and review and communicate the impact on the overall business.
- Lead supplier development strategy, designing the metrics for the function and supplier performance.
- Manage receiving inspection.
- Carry out supplier validation audits, with supplier support and supplier product FAI and feasibility study.
- Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements.
- Support new product launches to ensure suppliers are capable of delivering to the required quality standards.
- Manage the root cause analysis and corrective actions process of supplier quality issues.
- Review and evaluate supplier quality data to identify process improvement opportunities within the supply chain.
- Where appropriate work with the supplier directly, create corrective action plans to address process failures.
- Promote the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Error Proofing, Measurement System Analysis and FMEA (Failure Mode and Effects Analysis).
- Manage the Supplier Key Performance Indicators (KPIs).
- Lead quality audits for suppliers.
- Ensure compliance and assist with adherence to the Quality Management System (ISO9001:2015).
- Support regular inspection meetings with representatives from appropriate departments to establish an action plan for improving build quality.
- Keep up with current and developing manufacturing and engineering trends that concern product quality.
- Undertake personal continuous training and development.
- Lead the ECO, DEV, MCO processes, sign off, implementation and closure.
- Manage, coach and develop a high performing Quality and Regulatory Compliance team that meets agreed objectives and which delivers best practice results, added value and continuous improvement.
- Provide leadership, direction, management and development to Hardware Team.
- Consistently promote high standards through personal example and roll out through the team so that each member of the team understands the standards and behaviors expected of them.
- Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product requirements.
- Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
- Proactively contribute to creating a good team atmosphere.
- Anticipates and overcomes obstacles.
- Embraces personal challenge.
- Excellent interpersonal skills.
- BS – Engineering, Quality, Supply Chain or similar.
- 5-7 years’ experience with supplier quality, audits, and continuous improvement in a high volume electro-mechanical manufacturing organization.
- In depth knowledge of Machining, Molding, & Circuit Board fabrication and assembly along with testing and trouble-shooting of electronic assemblies.
- Possess ISO 9001 or equivalent QMS knowledge.
- Possess knowledge of inspection/test equipment (ex. Caliper, Micrometer, Thread Gauges).
- Ability to multi task.
- Experience with managing tasks effectively in a fast paced work environment.
- Ability to manage a variety of cross-functional team members.
- Competent in problem solving, team building, planning and decision making.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Working knowledge of Microsoft Office (Word, Excel, etc.).
- 25% travel required.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.