Advanced Process Quality Engineer - 23356BR - EN in Arroyo at Stryker Corporation

Date Posted: 4/4/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Arroyo
  • Job Type:
    Quality Assurance
  • Experience:
    Not Specified
  • Date Posted:
    4/4/2018
  • Job ID:
    23356BR

Job Description

Who we want
  • Challengers. People who seek out hard projects and work to find just the right solutions.
  • Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Customer-oriented achievers. Representatives with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Game changers. Persistent people who will stop at nothing to live out Stryker’s mission to make healthcare better.

What will you do
As an Advanced Product Quality Engineer you’ll be:
  • Responsible for the evaluation of process risks and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release).
  • Implement internal detective process controls.
  • Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
  • Verify gage repeatability, reproducibility, and accuracy, and address deficiencies.
  • Support the development and documentation of inspection methods.
  • Ensure potential process failures are reproduced and/or tested to evaluate internal and external impact.
  • Support the identification of suppliers and supplier development activities to ensure compliance and business continuity.
  • Lead supplier component qualifications through Production Part Approval Process (PPAP) and ensure appropriate controls are placed at the suppliers to ensure and verify components quality.
  • Collaborates with Advanced Manufacturing Engineer in all process validation activities to ensure consistent, repeatable and effective processes are implemented during design/manufacturing transfer.
  • Develop statistical rationale for testing.
  • Develop the rationale for validation sample size, duration, and number of runs.
  • Ensure worst-case scenarios are challenged during the process development and/or validation.
    • Eliminate waste from the processes (i.e. scrap, rework, wait times, etc).
    • Develops sterilization validation strategies with Subject Matter Experts and is responsible to execute and document such validation activities.
  • Compliance:
    • Continuously fully comply with all quality regulatory requirements.
    • May support internal and external audits.
    • Commit to environmental policy.
    • May train others in quality assurance/GMP related topics.
  • Prepare product and operations for transition, by training quality assurance engineers and inspectors and conducting knowledge transfer activities.
  • Lead quality activities during Post Launch Monitoring
  • Measure, Analyze and report key process indicators.
  • Develop the quality report and communicate product/process performance to the
  • Operation Unit assigned for new products.
  • Stop further processing in the event of encountering non-conforming product condition.
  • Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.
  • Advanced Responsibilities
  • Has some latitude for unrelieved action or decisions
  • Usually works with minimum supervision on routine work and detailed instructions on new projects or assignments; conferring with superiors on unusual matters.
  • Customer Service Orientation: Keeps customer (internal and external) need in mind when approaching all tasks and decisions.
  • Collaborative Teamwork: Works effectively with others to achieve team an organizational goals.
  • Individual Influence: Influences others of the merits of own point of view and earns their support. Possesses personal credibility and inspires confidence, handles opposition constructively, and treats others with respect.
  • Engagement: Encourages, inspires, and influence others, creating a positive impact on the
  • team, builds an engaged employee team in pursuit of the shared vision.

Job Requirements

What you need
  • Excellent interpersonal communication, collaborative team work, and negotiation skills.
  • Blueprint/engineering schematic reading and interpretation.
  • Must be able to analyze and correct complex process and/or system issues of a broad
  • scope using independent judgment.
  • Basic inspection techniques.
  • Basic PC skills.
  • Financial knowledge.
  • Excellent written/oral communication skills.
  • Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer,
  • wrenches, etc.), power tools and test/inspection equipment.
  • Demonstrated mechanical/electrical troubleshooting and problem solving skills.
  • Strong knowledge in Validation per FDA-QSR and ISO guidelines.
  • Statistical Knowledge: basic concepts (mean, Pp, Ppk, Normality, Hypothesis testing…)
  • and graphical tools (Box-Plot, Pareto, Histogram, etc).
  • Technical writing skills.
  • Effective presentation skills.
  • Basic knowledge on Sterile Packaging technologies and standards.
  • Bilingual (English and Spanish).
Required Experience:
  • 3-5 year minimum in Quality Assurance or related functional area such as Design
  • Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry.
  • Knowledge of inspection methods in the design and production of electro-mechanical
and/or mechanical equipment.
  • Possess attention to detail
  • Eagerness to assist internal and external customers
  • Manage projects in a timely manner
  • Ability to conduct and document technical investigation
  • The following experiences/skill sets are highly desirable:
  • ISO 13485 and ISO 14971
  • Industrial statistical techniques
  • Development and implementation of design and process controls
  • Geometry Dimensioning &Tolerancing
  • Experience with SPC
  • Familiarity with FDA Guidance on Design Controls and CAPA Methodologies
  • Familiarity with the Quality System Regulation 21 CFR Part 820, and CGMP
  • Experience with Design for Manufacturing
  • Manufacturing Experience
  • Knowledge of Poke Yoke (Error-Proofing) techniques
  • Human Error Prevention and/or Reduction techniques
  • New Product development/R&D experience
  • Experience on participation providing support or defending during third party audits
  • such as TUV, FDA, others.
Required Education and Training:
  • B.S. in engineering, engineering related discipline or equivalent experience.
  • ASQ-CQE or CQA desired.

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