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Quality Engineer - Senior

Eingestellt von Larson Group

Gesuchte Skills: Engineering, Support, Engineer

Projektbeschreibung

QUALITY ENGINEER - SENIOR - 14731

Engineering + Statistical Process Control + Control Plans and FMEA + Manufacturing + Product Management + Risk Management + FDA + ISO + Statistics + Lean Six Sigma + 21 CFR 820 + 21 CFR part11 + ISO 13485:2003

ROLE PURPOSE:

- To provide Quality Engineering support for several quality improvement initiatives, including new equipment validation.

ESSENTIAL SKILLS:

- A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
- Knowledge on Statistical Process Control, Control Plans and FMEAs is required.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.
- Previous experience working in a regulated industry, minimum of two years working in an FDA regulated environment.
- Experience in document authoring of validation deliverables.
- Self-directed; ability to work with minimal direct supervision
- Verbal and written communications
- Negotiation
- Problem-solving
- Proactive problem resolution
- Change Management
- In depth knowledge of 21 CFR 820, 21 CFR part11, ISO 13485:2003 and European regulations associated with the medical device industry
- In depth knowledge of GAMP 5 and SDLC process methodologies.

DESIRABLE SKILLS:

- Knowledge of bespoke computer software and/or hardware specification, testing and documentation
- Knowledge of the specification, testing and implementation of automated equipment with integrated and networked software applications
- Experience in in the validation of the following (SCADA, PLC, Vision systems, Firmware, MES, Database and bespoke applications)
- Software risk assessment and risk based testing methods

RESPONSIBILITIES:

- Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
- Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Support the implementation of electronic batch records and automated Statistical Process Control software
- Review/analyse whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc.
- Partners with 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.
- 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.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- To prepare and issue Validation Master Plans, Protocols, Summary Reports and other documentation associated with equipment and process validation of, as appropriate for each validation exercise.
- To ensure all validation activities and documents are authorised and appropriate compliance approval is gained
- To ensure that all validation activities are carried out and reported in a timely manner
- Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Larson Group