Requisition ID: 22303BR Job Title: Advanced Quality Engineer Division: International Ops Business Unit: Puerto Rico Ops Business Function: Quality Assurance Safety Business Sub Function: Country: United States State: PR City: Arroyo Shift: Job Description: Basic Function:
- Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments. Knows and applies the fundamental and some advanced concepts, practices and procedures of the advanced quality specialization.
- Support the required stages defined in the design cycle ensuring compliance with the current design control and transfer regulations and policy.
oStop further processing in the event of encountering non conforming product condition.
- Collect, interpret, and determine the root cause of failures
oDevelop the quality report
oDevelop and communicate the reliability and warranty goal to the Operation Unit assigned for new products
oResolve testing corrective actions and determine the necessary corrective and preventative actions
oConduct design reviews and track all findings
- Identify and track potential product and process risks.
oConduct risk analyses and track all findings
oRelease customer preference test and customer confirmation test units for shipment
oDevelop the risk management portfolio
oConduct audits as specified by the divisional schedule and as determined by new product development needs
oDevelop quality-related specifications and tests for software projects.
oWrite safety, durability, craftsmanship, and reliability design input specifications from Quality report, design reviews, risk analyses, and customer research
oDevelop statistical rationale for testing
oDevelop the rationale for validation sample size, duration, and number of locations
oImplement internal detective process controls
- Assist and develop process controls
oSpecify which preventative and detective controls are required, and communicate to vendors, internal/ external clients
oVerify gage repeatability, reproducibility, and accuracy, and address deficiencies
oDevelop and document the inspection methods
oDevelop the budget and schedule for process controls
oValidate vendor-implemented process controls
oPerform tool validation for off-the-shelf and custom test fixtures for software projects.
oPerform validation of software controlled production test system / equipment for software projects.
oTrain quality assurance engineers and inspectors
- Prepare product and operations for transition
oHandle quality assurance engineering responsibilities after launch
oPrepare risk management portfolio for long term maintenance by the Quality Engineer.
oHas some latitude for unrelieved action or decisions
- Advanced Responsibilities
oUsually works with minimum supervision, conferring with superiors on unusual matters.
oViewed as a team resource in the area of expertise.
oCommit to environmental policy.
oMay train others in quality assurance/GMP related topics.
oContinuously fully comply with all quality regulatory requirements.
- May coordinate the activities of one or more Quality Control Inspectors and/or technicians.
- May evaluate the performance of one or more Q.C. inspectors and/or technicians based on pre-established performance parameters.
- Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Generally involves sitting most of the time.
- Very good visual acuity.
- The ability to work with and inspect very small objects and/or tools and component parts.
- May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.
- Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.
- Requires use of safety glasses in designated areas.
- Closed-toe shoes must be worn on the production floor; safety shoes are recommended.
- Must be able to observe and note minute inconsistencies.
- Must be able to generate, follow, and explain detailed instructions and inspection procedures.
- Must be able to complete detailed documentation accurately.
- Must be able to communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel.
- Must be able to analyze and resolve non-routine product issues using independent judgment and inspection equipment.
- Effective interpersonal skills.
- Blueprint/engineering schematic reading and interpretation.
- Basic inspection techniques.
- Basic PC skills.
- Leadership skills.
- Good interpersonal and team skills.
- Problem solving and decision making skills.
- Innovation and resourcefulness.
- Planning and organizing skills.
- Financial knowledge.
- Excellent analytical skills.
- 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.
- Strong Statistical Knowledge (SPC,DOE, CPk, etc.).
- Technical writing skills.
- Fully bilingual (English and Spanish).
o ISO 13485 and ISO 14971
- 3-5 year minimum in Quality Assurance or related functional area.
- 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:
oIndustrial statistical techniques
oDevelopment and implementation of design and process controls
oGeometry Dimensioning &Tolerancing
oSix Sigma Black Belt Certification preferred
oExperience with SPC
oFamiliarity with FDA Guidance on Design Controls and CAPA Methodologies
oFamiliarity with the Quality System Regulation 21 CFR Part 820, and CGMP
oWork experience with a medical device manufacturer preferred
oExperience with Design for Manufacturing
oKnowledge of Poke Yoke (Error-Proofing) techniques
o510(k) submission experience
oNew Product development/R&D experience
Required Education and Training:
- B.S. in engineering or engineering related discipline.
- ASQ-CQE or CQA desired.
- Strong knowledge in Validation per FDA-QSR and ISO guidelines.
- Strong Statistical Knowledge (SPC, DOE, CPk, etc.). Qualifications/Work Experience: 3-5 year minimum in Quality Assurance or related functional area. 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: o ISO 13485 and ISO 14971 oIndustrial statistical techniques oDevelopment and implementation of design and process controls oGeometry Dimensioning &Tolerancing oSix Sigma Black Belt Certification preferred oExperience with SPC oFamiliarity with FDA Guidance on Design Controls and CAPA Methodologies oFamiliarity with the Quality System Regulation 21 CFR Part 820, and CGMP oWork experience with a medical device manufacturer preferred oExperience with Design for Manufacturing oManufacturing Experience oKnowledge of Poke Yoke (Error-Proofing) techniques o510(k) submission experience oNew Product development/R&D experience Percent Travel Required: 25
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