This is a leadership position supporting the Smith Medical Supplier Quality group. Own leadership responsibilities with respect to all Quality System aspects of the Purchasing and Supplier controls, including Quality oversight for New Product Introduction (NPI) and Article Quality Assessment (AQA) process. Act as the point of contact for all strategic issues related to suppliers' performance and continuous improvement activities. Partner with site(s) functions and Operations to lead the oversight of supplied products & services, ensuring conformance to purchased materials or finished devices requirements. Manage supplier changes and nonconforming product events, in compliance to Smiths Quality System, FDA QSR's, and International requirements and Quality System Regulations.
Duties and Responsibilities
Lead a team of Supplier Quality engineering professional in the day to day oversight of Product and Service providers ensuring sustaining Supplier Quality management activities i.e. new Supplier selection, approval, change control process, Supplier SCAR, CAPAs, Supplier Performance measurement and oversight & trending including Audits, Scorecard monitoring are conducted as defined by procedural requirements.
Develop people to achieve high performance by providing work direction and objectives, oversight, coaching and mentoring to engineers, as well as talent development. Represent Supplier Quality on central Supplier Quality team decisions & Sourcing council forum.
Lead Supplier Quality risk reduction programs with key suppliers as identified per plans.
Partner with key stakeholder including sourcing organization to drive quality & cost improvement efforts.
Ensure Compliance to Suppliers Controls and QS requirements.
Support ongoing harmonization efforts including the leadership of deployment of new or changing requirements within Purchasing and supplier controls process and associated systems.
Develop goals and strategies for Supplier Quality organization in line with budget and business plans and ensure staff are fully aligned with objectives and expectations
Ensure timely completion of staff appraisal.
Lead the implementation of the supplier change notifications and ensure appropriate oversight of supplier change process that assures all qualification and validation activities are meeting pre-defined Product and Process specifications.
Manage external supplier audits program and ensure execution of audits per Audit program requirements.
Manage Supplier Product and Process deviation investigation, associated with purchasing and supplier controls
All other duties as assigned.
Travel requirement: 50-60% domestically and/or internationally.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Required Skills and Experience
A minimum of a Bachelor's degree is required, preferably in an Electrical, Mechanical Engineering or Sciences discipline. MBA/MS degree preferred.
A minimum of ten (10) years related experience required, preferably in a Quality Engineering or related function.
Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485:2003 are required.
Six Sigma Green Belt or Black Belt certification is preferred.
Quality System Certified Lead Auditor required.
Experience managing people (leadership skills)
Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
Oral and Written communication skills
Ability to work & lead a team/partnership environment
Computer Skills (Agile, Word, Excel, Project, PowerPoint).
Effective at building, structuring and leading global teams potentially comprised of both direct reports and cross-functional resources.
Fifty percent 50% travel domestically and internationally will be required.
Understanding of what world class execution requires
Must be able to work independently with limited direction, partner with appropriate departments, and communicate effectively with all levels in the organization and mentor others to enable them to learn specific skills or knowledge while providing coaching, useful feedback, and direction to direct reports and teams.
Proven ability to establish, maintain and influence effective working relationships with internal and external customers.
Ability to prioritize and effectively handle several assignments/problem situations/ projects.
Ability to work effectively independently, as a team member, and as a team leader.
Ability to develop and present business results to the Operations Council, clients and customers.
Proven ability to coach and mentor others.
At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world's healthcare markets.
Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.
Smiths Medical is an EEO/AA Employer/Vet/Disabled
If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).