Quality Engineer 2
Quality Engineer 2
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Job Description
EXPERIENCE AND EDUCATION
- Refer to Table A for Education and Job Experience for each level.
- This position will require relevant experience working in manufacturing/operations.
- A minimum of a bachelors Degree preferably in Engineering or related technical field.
- From 2-4 years related experience.
- Bachelors Engineering Degreepreferably or related technical field.
REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS.
- ForQuality Engineer IILevel:
Experience working in both an FDA and European regulatory environment is preferred.
Experience with implementation of risk mitigation is preferred.
Technical training and experience using Statistics Lean and Six Sigma Methodologies is preferred including Measurement System Analysis SPC DOEs Reliability etc.
Knowledge of statistical software packages is preferred with the ability to preview graph and analyze data and be able to present data that facilitates/drives decision making.
The ability to perform hands on troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
Good technical understanding of manufacturing equipment and processes is required.
Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
ADDITIONAL POSITION REQUIREMENTS
Ability to organize and follow up on multiple priorities.
Ability to make decisions which will effectively support the business and company policies.
General knowledge of computer usage and applications.
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
This position is responsible for manage the following functions: Finished Goods Quality technicians and/or Quality Engineering technicians and/or Quality Laboratory Technician and/or Raw material quality inspector
This position reports to Quality Operations Manager
Resides as back up of Quality operations manager for signature authority and meeting representation with prior authorization
Receiving and greeting visitors
Participates in the interview and selection of qualified employees for authorized job openings
Works with other department such as human resources purchasing payroll and the controllers office to ensure that a variety of business transactions are completed
Ensures that the disciplinary actions are executed in a fair and consistent manner according to Company rules and policies.
Host business meetings with other functions
PHYSICAL WORKING CONDITIONS / REQUIREMENTS
This position will be performed in a clean room production environment which requires certain preparation and gowning practices
Office environment
LOCATION & TRAVEL REQUIREMENTS
- ForQuality Engineer IILevel:
This position may require up to 30% travel and will be based in an MD&D manufacturing facility.
- ForSenior Quality Engineerlevels:
This position may require up to 30% travel and will be based in an MD&D manufacturing facility.
- ForStaff and Principal Quality EngineerLevels:
This position may require up to 30% travel and will be based in an MD&D manufacturing facility.
- This position is required to be physically in applicable manufacturing location.
- Indicate the percentage of expected travel for domestic international or both.
EXTERNAL INTERACTIONS
This position interacts with sister manufacturing plant contacts to followup business needs quality issues improvements etc.
This position interacts and host contacts/audits with external competent authorities as deem necessary including but not limited to FDA BSI MDSAP ANVISA Auditors.
COMPANY DISCLAIMER
Company management reserves the right to add delete or otherwise alter assigned duties at any time. To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Johnson & Johnson companies are equal opportunity employers
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Ethicon Endo Surgery (Planta Independencia) a Johnson & Johnson company is a trusted world-wide leader in medical devices company who contributes to the advance surgery and improves lives every day. We are qualified as one of the top best place to work. Joining ETHICON is more than joining a great company it means being a part of a legacy of innovation development and philanthropy. For more information visit
Searching the best talent for: QUALITY ENGINEER II
JOB SUMMARY
Under the direction of Quality Operations Managerand with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirementsadministers Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain including Project support in day to day activities supporting manufacturing lines operator certification program incoming and finished good inspections and CME environmental monitoring all in accordance with applicable regulations and Ethicon written specifications and quality standards.
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DUTIES & RESPONSIBILITIES
Responsibilities may include but are not limited to:
The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of person will support processes in base business.
Business Improvements
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Review/analyze the effectiveness of PDCA Six Sigma Kaizen Lean Techniques and/or other improvement tools and programs.
Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management.
Compliance/Regulatory
Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs ISO 13485 etc.
Champions compliance to applicable Global Regulations and standards (e.g. QSRs ISO EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
Conduct periodic line audits to assess for production controls such as lot results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction
Partners with R&D and other cross functional partners to ensure the proper application of design controls risk management and the investigation/correction of design failures/challenges.
Supports the development of quality strategies related to the transfer of products materials and components within J&J or new product introduction as part of design transfer.
People
As applicable provides supervision mentoring coaching performance review and developmental plans for others
Product Quality Control & Disposition and Performance Standards
Lead and maintain Material Review Board.
Conduct investigation bounding documentation review and approval of non-conformances CAPAs and customer of quality issues as appropriate.
Accountability and ownership for material identification material segregation classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
Analyze/review effectiveness of preventive and corrective root cause investigation according to an established process.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Product/Process Qualification
Approve IQ OQ PQ TMV or Software Validation
Production/Process Controls including Control Plans
Partners with J&J Global Supply chain Finished Goods and material suppliers to ensure appropriate application of process validation process control and risk management; and the investigation/correction of process failures when needed.
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
Develop measurement systems/capabilities destructive tests non-destructive tests for manufacturing processes
Develop control plans consistent with product classification potential defect types defect frequency severity patient risk process capability process controls etc.
Develop interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Develop interpret and implement standard and non-standard sampling plans
Assess effectiveness of measurement tools destructive tests non-destructive tests measurement system analysis.
Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification potential defect types defect frequency severity patient risk process capability process controls etc. including assessing applying and interpreting acceptance sampling standard for manufacturing data.
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
Risk Mitigation
Document justify review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
Assess the need for risk mitigation techniques given product classification potential defect types defect frequency severity patient risk process capability process controls etc. Determine effectiveness of these techniques on previously implemented improvements
Ownership and accountability of risk assessment process including conducting documenting reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes
Strategic
Conduct strategic planning with site leaders and Product Engineering with other functions to establish business priorities and resource allocation
Ensures effective quality strategies are created for the validation of test methods process and design
Employment Type
Full Time
