Supplier Quality Engineer II

12-month contract, potential for extension or conversion (medical, dental, vision benefits offered - no PTO/holiday pay) Pay: 45-53/hr (based on experience) Top Needs/Skills: 1.

Lead, support, review and approve supplier change request (SCR), Validation, TMV, PPAP, CAPA, QMS etc.

2.

Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities Quality Plans, Control Plans, and FMEAs 3.

Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

Education Required: Bachelor’s Degree in Engineering/Scientific/Electronic or technical field Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies.

Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, qualification, manufacturing, QMS development, and technical quality/service/costs improvements.

Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, SCR, Quality Plans, Control Plans, and FMEAs Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items made for the business.

Lead PPAP qualifications with the CMsCollaborate with CMs to develop robust SCAPAsSupport the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAsDevelop, implement, and monitor CMs/Supplier's development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities, that align with the C&RM or/and business strategic goals and objectivesCollaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plansBuild and own the strategy for managing the CMs/Suppliers for the businessCommunicate with the business Quality lead on CM initiatives, updates, and issuesPartner with Supplier Quality Managers to build a strategy for managing the CMs in all regionsEnsure CM compliance with business Quality Systems and all relevant internal procedures and policiesFacilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMsManage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMsDevelop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at CMsDefine and manage the process for growing effective "partnerships" with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial successLead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization Maintain compliance to set Key Performance Indicators for the businessMaintain the highest level of compliance and operational standards set by the businessManage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulationsTranslate engineering, manufacturing, and quality requirements for CM productsPerform deviation investigations into quality issues arising from CM activitiesManage qualifications of changes and co-ordinates associated change control activitiesEvaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systemsResponsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintainedParticipate in annual supplier forums and business reviews Experience: Demonstrated track record of effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives Demonstrated knowledge and expertise in: supply chain management and supplier development, stakeholder management, risk/issue management, implementation planning, training/communication, scope managementKnowledge of plant operations preferredDesign Control knowledge preferredKnowledge of sterilization methods preferredThorough understanding of the US and international regulatory and quality assurance requirements associated with the development and manufacture of medical devices or drug productsElectronics Qualification/Experience would be an advantageWorking knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage and device regulationsKnowledge of Quality System Regulations (QSR) and ISO requirementAbility to budget for future expenditures and manage departmental budgetAbility to prepare and execute effective presentations to othersISO 13485:2003 Certified Lead Auditor6 Sigma and/or Lean experience preferred (trained or certified) Qualifications - Must Have: Minimum RequirementsBachelors degree requiredMinimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience