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Supplier Qual Engineer II

North Haven, CT 06473

Posted: 09/12/2023 Employment Type: Contract Job Category: Engineering Job Number: 585601 Is job remote?: No Country: United States

Job Description


Top 3 technical  skills that you are looking for in a candidates experience:
  1. Lead, support, review and approve supplier change request, Validation, MSA, PPAP, etc.
  2. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, to include SPC, Quality Plans, Control Plans, and FMEAs
  3. Familiar with the Medical industry requirements such as ISO 13485

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.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs

What is your timeline for scheduling interviews? ASAP

What product line will this person support? Surgical Robotics


Are you a passionate, dedicated, and motivated Supplier Quality Engineer who will thrive in a role that provides Quality Engineering support and leadership to partner with the company’s suppliers, and their respective processes/systems to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products?

 

As a  Supplier Quality Engineer, you will communicate and resolve supplier-related problems as they occur.  You will be responsible for providing guidance and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured in accordance to applicable industry standards, regulatory requirements, and customer requirements.
 
  • Expertise in equipment qualification, process validation (IQ, OQ, PQ), inspection techniques including qualification, risk-based sampling plans, statistical analysis, statistical process control, control plans, first article inspection, PPAP, and FMEAs.
  • Lead root cause analysis
  • Train CM on the root cause analysis and DMAIC methodology
  • Partner with CM on in-process monitoring implementation and process improvement
  • Be the supplier quality expert to assist project team members in processes, procedures, and improvements.
  • Manage supplier oversight and monitoring activities (KPI’s)
  • Represent the supplier quality engineering function to develop and execute a strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items made for the business
  • Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
  • Establish and successfully execute supplier management plans that will align with overall business objectives. 
  • Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Quality deployment, and Control Plans for new products.
  • Work with new and existing CMs to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs
  • Be the supplier quality expert to assist project team members in processes, procedures, and improvements.
  • Manage supplier oversight and monitoring activities (KPIs)
  • Partner with Sourcing to ensure the proper inspection methods and drawing requirements are communicated, understood, and delivered to suppliers.
  • Qualify suppliers according to company standards and processes
  • Develop, 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 CMs
  • Define 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 success
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • Assist in establishing supplier quality agreements to ensure compliance with requirements.
  • Delivers strategy on non-conformance management including but not limited to Supplier Change Requests (SCR), Supplier Corrective Actions (SCAR), and complaint investigations.
  • Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR, and others.  Support internal, corporate, notified body, FDA, and other audits.  
  • Collaborates with contract manufacturers to evaluate supplier scorecards and address low-performing suppliers with appropriate corrective action plans.
  • Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products.
  • Drives Quality Begins with Me initiatives in collaboration with cross-functional stakeholders and contract manufacturers where necessary.
  • Evaluate 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 systems
  • Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained
  • Work-related travel (Domestic and overseas) ~ 25%

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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