Hi Partners,
Greetings,
Hope you are doing Well!!!!!!!!!!!!!!!
Please forward a profiles to shankar@techconsultinc.com
Here are the requirement details
Louisville, CO
Quality Engineer
4+ Month Contract
POSITION DESCRIPTION
Collaborate with suppliers to ensure product specifications are met. Recommend, plan and lead corrective and preventive actions for continuous improvement with suppliers under general supervision. Work with Suppliers and MNAV purchasing to ensure that supplier management files are maintained according to established requirements to include the development and management of supplier control plans. Conduct supplier audits as required.
Participates in investigations, analyzes data, assists in root cause analysis, and prepares reports, as required. Ensures all activities and record-keeping are performed in compliance with the Quality System. Develop, advocate and enable process improvement tools and methodologies to drive process excellence related to Supplier Quality, Supplier Management, and Product Quality. These tools may include, but are not limited to: Lean Sigma, project management, and other improvement techniques.
POSITION RESPONSIBILITIES
Knowledge:
Frequent use and application of technical standards, basic principles, theories, concepts, and techniques.
• Maintain and recommend updates as required to RIR and PPAC inspection documents, including updates to sampling plans based upon regular review.
• Provide information or data related to improvement efforts relevant to documentation, processes, inspection methods or related criteria.
• Works from standard operating procedures and other established specifications to maintain compliance with applicable regulations.
• Provide well-written reports and supporting documentation.
• Interface as primary Quality contact with select suppliers to ensure product specifications are met.
• Participate in supplier management activities such as scorecarding, supplier risk assessments, and similar.
• Engage suppliers to establish appropriate qualifications, validations, inspection plans and gauging for both new products and changes to released product.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment with respect to suppliers.
• Collaborate with suppliers regarding the performance of machine and process capability and performance studies.
• Support the implementation of changes and upgrades to systems, procedures, and processes to improve product quality
• Interface with suppliers to ensure product specifications are met and control plans are implemented.
• Disposition nonconforming product at the Material Review Board meetings based on product knowledge and critical thinking.
• May lead supplier audits and assessments, and ensure identified audit non-conformances are resolved in a timely manner.
• May participate in the product development cycle to drive supplier selection process.
Problem Solving:
Provides solutions to a variety of technical problems of moderate scope and complexity.
• Escalate and lead root cause investigation of quality and yield issues to ensure production of safe and effective medical devices. Interface with peers and other functional groups in resolving those issues.
• Assist in the assessment of the supplier program and recommend solutions/improvements.
• Lead process improvement projects as assigned by Manager or IQA Supervisor.
• Utilize Lean Sigma (or similar) project management tools as appropriate to include DMAIC methodology, value stream mapping, visual management, financial analysis, etc.
• Provide analysis in the evaluation of customer complaints related to areas of NCMR in IQA.
• Identify and implement supplier corrective and preventive actions to improve quality and reduce incoming quality NCR's.
BASIC QUALIFICATIONS
EDUCATION REQUIRED
• Bachelor's Degree in Engineering
YEARS OF EXPERIENCE
• 2+ years of previous experience in a supplier quality position in a regulated environment with B.S.
• 0+ years of previous experience in a supplier quality position in a regulated environment with M.S./M.A.
DESIRED/PREFERRED QUALIFICATIONS
• Understanding and application of cGMPs/AATB, FDA, ANSI Z1.4 Sampling Plan and Medical Device Regulations.
• Solid knowledge of Engineering drawings and specifications and inspection sampling plans.
• Quality or Regulatory Certification (i.e. ASQ)
• Experience with Access databases
• Process improvement experience (i.e. Lean or Six Sigma Training)
• Use and understanding of Statistical Tools
• Proficiency in SAP
• Supplier Auditing Training and Certification
• Auditee Experience
Looking forward to hearing from you at the earliest!!!
Regards
Shankar
Professional Recruiter
33505 State Street, Suite # 200 Farmington, MI 48335
V (248)-522-6879
F (248)-579-4454
Linkedin: www.linkedin.com/in/shkrajan
Email : Shankar@techconsultinc.com
Messanger: shankarraj001@yahoo.com
Minority Certified and Woman Owned Enterprise
TCI- Technology Consultants inc
Note: It is not a solicitation attempt!!!
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