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Associate Quality Engineer
Requisition ID: 1805650320W
1. Overall responsibilities
The Associate Quality Engineer under general supervision conducts assignments involving a specific phase of an engineering project which may include design, development, manufacturing, construction, installation, operation and maintenance. The incumbent may assist in determining objectives and planning schedules of multiple projects with few complex features.
The Associate Quality Engineer will utilize 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 processes.
2. Position duties and responsibilities
- 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.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- 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 segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction:
- Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards:
- Supports activities related to the Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformance.
- Review root cause investigation according to an established process.
- Support the collection/presentation of Quality metrics including leading and lagging indicators of quality
- Write, review, execute and approve IQ, OQ, PQ, TMV or Software Validation
Production/Process Controls including Control Plans:
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Working in conjunction with other senior Quality Engineers, reviews effectiveness of current control plans given risk levels.
- Working in conjunction with other senior Quality Engineers, reviews the level of control in manufacturing processes including the adequacy of current process limits.
- Working in conjunction with other senior Quality Engineers, assess the current risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 0-2 years related experience.
- Knowledge of product/process Risk Management (FDA and ISO standards) is required.
- 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.
- Good technical understanding of manufacturing equipment and processes is required
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- Experience with implementation of risk mitigation is preferred.
Interpersonal skills / characteristics:
- 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
- Team player
Minimum Language required:
- English - very good
- German - very good in writing and speaking
Synthes Produktions GmbH (7117)