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Supplier Quality Engineer

Connexion Systems + Engineering

Manchester, NH, NH

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JOB DETAILS
SKILLS
Auditing, Best Practices, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Code of Federal Regulations, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Detail Oriented, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Manufacturing, Manufacturing Engineering, Materials Management, Medical Equipment, Microsoft Office, Multitasking, Presentation/Verbal Skills, Process Control Engineering, Process Improvement, Product Lifecycle, Project/Program Management, Quality Assurance, Quality Engineering, Quality Management, Regulations, Risk Analysis, Root Cause Analysis, Scorecarding, Software Testing, Standard Operating Procedures (SOP), Supply Chain, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Planning, Vendor/Supplier Relations, Willing to Travel, Writing Skills
LOCATION
Manchester, NH, NH
POSTED
30+ days ago
Supplier Quality Engineer


Position Overview:
This position will help manage and improve the overall quality of our supply chain partners and help ensure that we are compliant to ISO 13485 and FDA requirements as relates to our suppliers and supplied parts. This position will be part of our Quality team, and will work extremely closely with our Incoming Inspection, Engineering and Material Management team. This role will be the primary driver of disposition and closure of Supply based NCR activity.  This role will also weigh in on all matters pertaining to quality, engineering and continuous improvement throughout the product lifecycle.

Responsibilities:
  • Assist inspection with evaluating cosmetic specifications and other intricate component requirements requesting input and communication with QE/ME as needed.
  • Interface with Incoming Inspection, discuss results, document disposition and required approvals to ensure timely closure of Nonconformance Reports.
  • Serve as key contributor at weekly Incoming Inspection NCR MRB meeting.
  • Utilize relationships with incoming inspection group and the supplier to investigate differences between measurements.
  • Communicate failures to suppliers, request SCARs where necessary and document effectiveness of corrective actions.
  • Work with Supply Chain to attain RMA numbers, ensure dispositions are carried out per NCR approval.
  • Generate and Distribute Scorecards to suppliers
  • Conduct ASL updates in PLM system for new suppliers, Supplier Change Notifications etc.
  • Interface with suppliers, Manufacturing Engineers and Quality Engineers to evaluate potential component issues.  Walk down processes vs supplier processes and determine root cause.
  • Work with Supplier Development and Sr. SQE to schedule telecons, investigate process control issues or breakdowns, identify high-risk suppliers, schedule for cause audits, etc.
  • Facilitate the review and approval of supplier-initiated changes requests, and communicate the approved changes through Quality and to the appropriate departments.
  • Look for opportunities to drive preventive actions and continuous process improvement with our suppliers.
  • Assist as needed with customer audits and regulatory audits.
  • Provide recommendations for improvements and help drive best practices to SOPs pertinent to QA GMP Compliance activities.

Qualifications and Skills:
  • 2+ years of experience in a Quality Assurance role, or with a medical device manufacturing company
  • Experience as a certified quality auditor or supplier auditor is a plus
  • Familiarity with ISO 13458:2016 and FDA 21 CFR Part 820
  • Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
  • A demonstrable ability to work with cross-functional teams comprised of members within and outside of our organization
  • Ability to work with CAD files and interpret mechanical drawings
  • Ability to analyze data for accuracy and correctly interpret results
  • Microsoft Office proficiency
  • Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel

Education: Bachelor’s in Engineering or related experience
 

About the Company

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Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/