iMPact Business Group
Registered
Job Type: 12+ month Contract
Pay Rate: $65/hour
Benefits: Medical, Dental, Vision
Apply to: [email protected]
Candidate will be performing on-site inspections for underperforming finished good supplier to detect and prevent nonconforming products. Candidate will be leading quality improvement and process improvements with the supplier.
Position Description
Working in partnership with our clients Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM's quality issues, development of suppliers and ensuring that our external supply chain is capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison between OEM/CM's and our client to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and OEM/CM's in support of quality issues; provide technical support for activities related to quality system assessment and performance evaluation.
You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of OEM/CM's to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
This role will provide coaching and guidance to the OEM/CM team to ensure compliance to technical, regulatory and our clients requirements.
Requirements
About iMPact Business Group
iMPact Business Group is a professional staffing agency located in Grand Rapids, MI, and Tampa, FL. We were founded in 2004 and service candidates and clients nationwide. Our areas of specialization are in IT, Engineering, Finance/Accounting, and Business Administration/Process (HR, Marketing, Admin jobs, etc). Opportunities are available nationwide as well as remote. We were ranked by FlexJobs as one of the Top 100 Employers for remote & hybrid jobs in 2023
Pay Rate: $65/hour
Benefits: Medical, Dental, Vision
Apply to: [email protected]
JOB DESCRIPTION
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Supplier Quality Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.Candidate will be performing on-site inspections for underperforming finished good supplier to detect and prevent nonconforming products. Candidate will be leading quality improvement and process improvements with the supplier.
Position Description
Working in partnership with our clients Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM's quality issues, development of suppliers and ensuring that our external supply chain is capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison between OEM/CM's and our client to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and OEM/CM's in support of quality issues; provide technical support for activities related to quality system assessment and performance evaluation.
You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of OEM/CM's to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
This role will provide coaching and guidance to the OEM/CM team to ensure compliance to technical, regulatory and our clients requirements.
- Ownership for OEM/CM quality performance and measurement including KPI's and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
- Lead quality issues with OEM/CM's & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned OEM/CM's.
- Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device's regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
- Responsible for accuracy and integrity of OEM/CM supplier data that ensures compliance with documented procedures & processes
- Ownership and reporting on all quality issues associated with the assigned OEM/CM's. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
- Participate in the OEM/CM material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
- Maintain structured communication channels with strategic sourcing, identifying responsibility by OEM/CM.
- Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned OEM/CM.
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
- Deliver continuous improvement activities focusing on OEM/CM quality
- Participate as required in SCRB in conjunction with key stakeholders
- Support assessment of OEM/CM supplier changes
- Participate in supplier audit program - planning, execution and closure
- Participate in supplier reviews for assigned OEM/CM's as required
- Participate in cross functional projects both locally & globally as required
- Partner with Strategic Sourcing on the developments and approval quality assurance agreements with OEM/CM's.
Requirements
- BS in engineering, or engineering related discipline required.
- 5+ years of relevant experience in Quality, Project Management, or Engineering.
- 2+ years experience with EUMDR / Medical Devices
- Experience working onsite developing suppliers preferred.
- Experience in production and process controls.
- Expertise in problem solving and root cause analysis
- Working knowledge of quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts.
- Demonstrated collaboration, negotiation, and conflict resolution skills.
- Ability to lead, champion change, and execute strategies to meet goals.
- Critical thinking and strong analytical skills.
- Familiarity with quality systems; ISO13485 & ISO9001 experience preferred.
- Advanced working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint 2007 .
- Technical understanding of manufacturing prints and tolerancing
- Knowledge in statistics
- Basic understanding of manufacturing processes
About iMPact Business Group
iMPact Business Group is a professional staffing agency located in Grand Rapids, MI, and Tampa, FL. We were founded in 2004 and service candidates and clients nationwide. Our areas of specialization are in IT, Engineering, Finance/Accounting, and Business Administration/Process (HR, Marketing, Admin jobs, etc). Opportunities are available nationwide as well as remote. We were ranked by FlexJobs as one of the Top 100 Employers for remote & hybrid jobs in 2023
