Quality Assurance Engineer

4 months ago

Scottsdale, United States Ziehm Orthoscan Full time

Ziehm Orthoscan Inc. a North Scottsdale Medical Device manufacturer located off the loop 101 and Raintree, is currently seeking a motivated, career-oriented professional with a positive can-do attitude to join our team as a full-time Quality Assurance Engineer.

Why Work for Ziehm Orthoscan Inc.?

There's something special about our Company. There's a sense of pride that comes from building a product that helps improve people's lives and making the most of ourselves as a company and as individuals. We know the success of the Company depends on every employee in our organization, it is our people who make the difference.

What do we offer?

  • The challenge of meaningful work - we offer constant opportunities to grow and develop world-class skills and a truly rewarding career.
  • A unique culture where people convert their passion into action.
  • The kind of competitive compensation you would expect from a world leader.
  • Nine paid holidays plus a generous PTO and vacation time plan.
  • Great benefit plans, major medical, dental and vision.
  • Company 401(k) plan with an employer match.
Job Summary:

Support Quality Assurance operational goals and objectives by focusing on the development and operation of quality control systems, the application and analysis of testing and the use of metric tools to produce deliverable outcomes. Key responsibilities include assessing, monitoring and reporting vendor and manufacturing quality data/statistics, analyzing quality data, developing and executing strategic plans for improvement, while developing, implementing and overseeing the effectiveness of supplier and manufacturing improvements. Other tasks include the review of proposed changes (ECR/ECO), non-conforming material processing and establishing/maintaining Quality System documents and records.

Essential Functions:
  • Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 801, 21 CFR part 803, 21 CFR part 806, 21 CFR part 820), EU MDR and other applicable standards.
  • Collect, compile, analyze and report quantitative and qualitive statistical quality data on suppliers and manufacturing and recommend corrections/improvements.
  • Track and communicate QA performance to Quality Review Board and facilitate/support problem solving, correction, improvement activities.
  • Support the QC Inspection team by planning/coordinating/monitoring improvements including creation/revision of documentation defining test methods and criteria.
  • Facilitate the creation, analysis, review and reporting related to supplier and manufacturing nonconforming material (NMR) process.
  • Identify, promote and implement Supplier Quality and Manufacturing Area correction/improvement activities applying basic LEAN techniques.
  • Prepare quality plans, inspection plans, process plans and reports, IQOQPQ, risk assessments or related documentation to communicate criteria and outcomes of new or changed parts/products/processes.
  • Facilitate the analysis, review and reporting related to supplier performance and produce timely supplier analysis.
  • Assess, qualify and certify suppliers. Maintain active supplier approval list (AVL)
  • Collaborate with other departments in the organization (i.e. Engineering, Sales, Operations, Product and Project Manager) to ensure that procedures align with overall organization goals with minimal risk.
  • Final Review and approval of selected Technical Documentation (DHR, DMR, etc.).
  • Support CAPA and Internal Audit processes / Complete assigned CAPAs, Internal Audits.
  • Timely and accurate completion of assigned tasks and reports associated with QARA
Basic Qualifications:
  • Bachelor's degree in Quality Engineering, Quality Assurance, Computer Science, Industrial Engineering or related engineering degree
Experience:
  • 5+ years of experience in a design and manufacturing medical device environment with emphasis on supplier and manufacturing quality assurance.
  • 5+ years of experience in application of LEAN, Six Sigma, SPC or similar evaluation techniques to improve processes and performance, increase efficiency, reduce waste, reduce costs, and elevate product quality.
  • Demonstrated achievements in proactively seeking out and addressing product/process errors that could otherwise be missed during development, launch or manufacturing
  • Demonstrated competency in mining, preparing and presenting meaningful information from diverse data sets.
  • Capabilities to track open issues in design, transfer, launch and post launch phases of product life cycle.
  • Certification and experience in operating in and auditing quality systems that are certified under an accredited program such as ISO9001, ISO13485, MDSAP, EU MDR.
  • Knowledgeable about receiving, in process, final Quality Inspection and Testing.
  • Quality Team Improvement Facilitator.
Desirable Skills and Competencies:
  • Ability to adapt and work efficiently in a rapidly changing dynamic environment with a willingness to manage multiple simultaneous projects.
  • Excellent data analyzing and review/critical thinking skills.
  • Effective project and time management skills.
  • Ability to teach and mentor.
  • Effective verbal and written communication skills.
  • Proven ability to think strategically about market needs, business impact and product design.
  • Proven ability to influence and collaborate without formal reporting relationships.
  • Ability to work professionally with many different personalities.
Working Conditions:
  • Work is performed onsite and in an office environment.
  • Typical work schedule is Monday - Friday, 7-4pm however this is subject to change depending on work demands.
  • Prolonged periods of sitting at a desk and working on a computer.
  • May require PPE and periodic exposure to low dose radiation.

We support a drug free work environment

EOE/M/F/Disability/Vet All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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