For our client in Neuchatel we are looking for a Quality Engineer for a 6-12 months project
Position overview
The Senior Validation Quality Engineer reviews and approves technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology. Contributes to the development, implementation and execution of quality systems in support of qualified. Ensures that validation and qualification activities are consistent with company validation policies and procedures and federal regulations. Proceeds according to the company's quality policy in all business activities with providers and customers within and outside the company. Evaluates technical problems and provides recommendations for corrective actions. Investigates deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature. Represents validation function in project teams, with the objective to assure that departmental quality objectives are met. Participates in company meetings related to changes in processes, process improvements, provide suggestions, and so on. Provides coaching and training and guidance on aspects of validations and qualifications. Provides support to internal and external customers of supplier quality in the execution of procedure and policy requirements. Acts as a major contact for validation issues during regulatory and third-party in. Writes, collects, organizes and communicates data to appropriate groups.
Tasks & Responsibilities:
* Review, update and implement EU MDR technical documentation for BSI submission
* Provides support in developing and approves operating procedures, manufacturing control plans, pFMEA.
* 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.
* Demonstrate proficiency in applying various tools and methods (for example, Process Excellence) to identify and realize process and business improvements.
* Partners with J&J Global Supply chain, R&D, RA and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
* Ensures that Process Quality control plans are in accordance with product risk level and are consistently followed. Implements and/or maintains production and process controls using appropriate techniques (for example process capability measures, statistical process controls, process performance metrics).
* 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.
Qualifications & Experience
Experience:
* A minimum bachelor's degree in Engineering or related technical discipline with a minimum of 5 years of experience in quality is required. A Master's or other advanced degree is a plus.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Experience working in both an FDA and European regulatory environment is preferred. Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required. MDR is a plus.
* Experience working on New Product Introduction process and Process Validation is required.
Interpersonal skills / characteristics:
* Ability to "think out of the box", flexibility, open-minded, team spirit and "can do" attitude are required personal skills. Good technical understanding of manufacturing equipment and processes is required.
* Proven evidences of multi-tasking and proven evidences of taking ownership of action outside of its direct field of responsibilities are required.
* Excellent problem solving, decision-making, and root cause analysis skills are required.
Minimum Language required
* Fluency in English is required.
* Fluency in French is required.
Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines