Senior Supplier Quality Engineer I

Integra LifeSciences

1d•$51,000 - $71,000

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Supplier Quality Engineer I is responsible for conducting supplier audits, administrate supplier corrective & preventive action reports (SCAR), certifying suppliers and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. This position will administrate the Supplier Management Program. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Consults with supplier’s management to establish and implement practices and procedures that comply with Integra requirements. Finally, assists to develop, implement and monitor quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO, the Medical Device Directive and other applicable regulatory agencies.

Requirements

Bachelors Degree in Engineering or science.
Five or more years experience required; in the medical device or pharmaceutical industry highly preferred
Must be thoroughly knowledgeable on cGMP’s, ISO 13485 and familiar with other Regulatory Requirements applicable to a medical device manufacturing operation.
Must understand and be able to apply basic inspection and testing techniques, including various types of sampling plans (i.e. ANSI/ASQ Z1.4, etc.)
Must perform statistical analysis and have ability to analyze data and communicate effectively in order to solve problems.
Must be able to use to utilize Six Sigma and Problem Solving techniques or Root Cause Analysis tools to resolve product/process issues related with purchased parts/components
Must understand and be able to apply the elements of corrective and preventive actions, including root cause analysis, failure mode and effects analysis (FMEA), and the control of nonconforming material.
Must be able to read, interpret and understand technical and non-technical documents, including but not limited to: contracts, product drawings (blueprints) and specifications.
Must know which measurement and test equipment (M&TE) tools are appropriate for various tasks and how to assess tool accuracy and precision; must understand the concept of standards traceability for M&TE.
Must have strong verbal and written communication skills.
Must be able to successfully interface with technical and non-technical personnel such as inspectors, designers, buyers, vendors, manufacturing personnel and management.
Must have demonstrated ability to think strategically.
Proven ability to effectively manage/lead multiple priorities is a must.
Must be fully bilingual (English/Spanish).
Willing to travel.

Nice To Haves

Six Sigma Certified, Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) preferred.
ISO 13485 lead auditor certification or equivalent is highly desirable. Previous experience in internal/external auditing .

Responsibilities

Support Supplier Certification Program.
Plans and conducts scheduled audits of suppliers to assess compliance with Integra requirements. Includes audit scheduling, investigation and evaluation of audit observation and findings, reporting, follow-up, confirmation of follow-up actions and effectiveness verification.
Approve and monitor supplier CAPA plans and activities to closure including objective evidence of effectiveness.
Conduct technical and statistical investigation on supplier quality problems and complaints.
Assess supplier capabilities through direct visits, technical discussions and Quality System Audits. Evaluate new potential suppliers and assist in their qualification.
Communicate quality issues and/or incidents to suppliers as needed and provides assistance to develop corrective actions.
Develop supplier quality performance metrics. Generates Quarterly Supplier Performance Reports. Prepare and provide information for Management Reviews.
Track and trends supplier performance, taking remedial action as needed. Work with Design and Development, Manufacturing, Purchasing and Quality Assurance in the monitoring supplier performance.
Contributes and participates in supplier performance reviews.
Evaluate vendor changes and submit Qualification Plan as required.
Update and enhance procedures (SOP) related with supplier approval and audits as required.
Evaluate questionable raw material, rejected units or non-conformances reported by incoming personnel by inspecting and testing as needed. Provide support on the assessment and disposition of non-conforming material.
Develop and audit of inspection criteria and methods at Incoming/Receiving Inspection. Evaluate and improve the current incoming inspections sampling plan for purchased parts/components. Identify and implement opportunities for continuous improvement.
Develop and implement inspection sampling plan and method for new purchased components.
Provides guidance to Purchasing and Engineers in applying supplier quality system requirements.
Train suppliers, auditors and other Integra personnel on QA specifications for suppliers.
Assist in failure investigation and problem solving exercises to identify effective corrective and preventive action (CAPA) in order to reduce product defects and customer complaints.
Ensure that all projects are in compliance with QSR (including Design Controls), ISO or other applicable requirements.
Participates in FDA inspections, ISO Certification and surveillance audits and customer audits as required.
Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
Supervise Supplier Quality Specialists.