Advanced Process Quality Engineer - Stryker (Puerto Rico)
**Requisition ID** 23356BR
**Job Title** Advanced Process Quality Engineer
**Group** Global Quality and Ops
**Division** SGS Advanced Ops
**Business Unit** AO Endoscopy
**Business Function** Quality Assurance
**Country** United States
**State/Province** PR
**City** Arroyo
**Employment Category** Full Time
**Percent Travel Required** Up to 10%
**Shift** 1st
**About Stryker**
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
**Job Description / Information**
**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.
**Minimum Qualifications**
**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 participationproviding 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.
All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
Stryker is an EO employer – M/F/Veteran/Disability