*Hi Partners,*


*Greetings,*



*Hope you are doing Well!!!!!!!!!!!!!!!*



*Please forward a profiles to **[email protected]*
<[email protected]>



*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*
<http://www.linkedin.com/in/shkrajan>

*Email** : **[email protected]* <[email protected]>

*Messanger**: [email protected] <[email protected]>*

*Minority Certified and Woman Owned Enterprise*

*TCI**- Technology Consultants inc*

*Note:* *It is not a solicitation attempt!!!*

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