Quality Engineer II

Company: Apex Systems ( Learn More )

General Information
US-CO-Louisville Colorado
N/A
4 Year Degree
Full-Time
At least 2 year(s)
Not Specified
False
False
Job Description

Seeking a Supplier Quality Engineer with 2+ years’ experience. Preferred experience includes medical device experience, understanding of cGMP’s/AATB, FDA, ANSI, knowledge of engineering drawings, Quality or Regulatory certification (ASQ), process improvement experience, etc. For immediate consideration, please send your updated resume to [Click Here to Email Your Resumé]

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 Medtronic Navigation, Inc. 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.
  • DESIRED/PREFERRED QUALIFICATIONS

  • Understanding and application of cGMPs/AATB, FDA, ANSI Z1.4 Sampling Plan and Medical Device Regulations.
  • Time management and organizational skills.
  • Tactical problem solving skills
  • Solid knowledge of Engineering drawings and specifications and inspection sampling plans.
  • Ability to multitask.
  • Quality or Regulatory Certification (i.e. ASQ)
  • Proven leadership skills and business acumen
  • Solid decision-making skills, taking into account all relevant factors and Stakeholders
  • Proven success in leading people to do things differently
  • Experience in coaching and mentoring
  • Ability to manage project deliverables from personnel that do not report directly to you
  • Experience with Access databases
  • Process improvement experience (i.e. Lean or Six Sigma Training)
  • Use and understanding of Statistical Tools
  • Capable of explaining the underlying concepts and principles of data analytic and statistical tools
  • Proficiency in SAP
  • Supplier Auditing Training and Certification
  • Auditee Experience
  • POSITION RESPONSIBILITIES FUNCTIONING FACTORS:

    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 score carding, 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 NCRs.
  • Supervision & Discretion/Latitude:

  • Works under general supervision.
  • Follows established procedures.
  • Work is reviewed for soundness of technical judgment and overall adequacy.
  • Follow all Quality System Practices and SOPs as defined by Medtronic MNav policies, practices and procedures to insure that FDA and ISO/MDD regulations are met.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • Maintains a clean and orderly work environment, leading 5S activities where appropriate.
  • Prioritizes workload demands, complex issues, and seeks supervisory support as conflict arises. Maintain a positive attitude when handling multiple work demands.
  • Responsible for handling escalated issues ordinarily encountered (i.e. SOPs, technical issues, departmental issues, supplier issues, etc.) and seeks supervisory input for complex, non-routine work.
  • Assigned special projects and reports when required
  • Consequence of Errors / Impact:

  • Contributes to the completion of milestones associated with specific projects.
  • Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
  • Investigates variances and timely escalates findings to manager or designee utilizing the NCR and CAPA procedures, as applicable.
  • Ensure timely release and segregation of all non-conforming materials for assigned suppliers.
  • Ensures traceability of components and assemblies.
  • Uses working knowledge of inspection techniques to determine the most accurate method of inspecting complex parts to drawings and specifications.
  • Contacts / Liaison:

  • Primarily internal company contacts.
  • Infrequent interorganizational and outside customer contacts on routine matters.
  • Regularly participate in cross-functional reviews with the Material Review Board (MRB).
  • Act as a resource to for others and provides information on the supplier management processes.
  • Change Agent:

  • Advocate and influence appropriate change and quality needs across affected functions, usually within Supplier Quality and Operations.
  • Enable quality efforts to be felt by both our customers and Medtronic employees.
  • Passionately drive process excellence visibility and awareness.
  • Work cooperatively with the manager and peers to address issues that arise from Production/R&D testing and special requests.
  • Foster good working relationship with co-workers and work collaboratively in a team environment with general supervision.
  • Ensure all activities are in compliance with the Medtronic Code of Conduct and demonstrate the Medtronic Traits.
  • Participates in team meetings.
  • Support other departments for prioritization of releasing NCMR materials.
  • Performs other duties as assigned.
  • BASIC QUALIFICATIONS EDUCATION REQUIRED

  • Bachelors 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.
  • SPECIALIZED KNOWLEDGE REQUIRED

  • Solid basic math, problem solving and deductive reasoning skills
  • Ability to easily read and understand verbal and written instructions, including technical information and all safety information.
  • Good communication skills, including writing, presenting, and comprehension of technical information. Attention to detail.
  • Proficiency in Microsoft Office (Word, PowerPoint, Excel, & Access).
  • Able to work within a team to meet business goals and objectives.



  • Job Requirements