Senior Quality Engineer
Job Description:
The primary function of this role is to provide technical leadership within the Quality Engineering team to support production, quality control, purchasing, facilities, IT, regulatory, analytical lab, research and development, and engineering sustaining teams.
This includes but is not limited to providing support to process validation, change requests, non-conforming product issues, corrective and preventive action program, design and process FMEA, risk assessment, and associated quality system documentation.
Key Responsibilities:
* Drive all assigned Quality Engineering projects and ensure they are managed in a structured fashion and completed in compliance with relevant procedures.
* Manage and drive project activities to ensure timely completion of project milestones.
* Represent the team at key review meetings.
* Work closely to build effective relationships with other functions, particularly operations, IT, engineering, and regulatory teams.
* Lead in the area of FDA, QSR, and ISO13485 requirements, promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Quality Engineering Manager as the final arbitrator on critical quality decisions.
* Identify and implement opportunities for improvement and implement under their own initiative.
* Maintain a proactive approach to developing the company's quality system to meet changing business needs.
* Ensure that in-house or external quality issues are effectively prioritized and acted upon in a timely manner.
* Demonstrated proven experience and proficiency across functional areas: design, process, risk management, software validation, supplier quality, CAPA, non-conformances, customer complaints, sterilization, statistics, facilities/environment, microbiology/biocompatibility, 6 sigma/lean/continuous improvement.
* Support the internal audit, supplier audit, and regulatory audit programs.
* Prepare, execute, and analyze quality engineering documentation.
* Trending and analysis of key quality metrics.
* Responsible for the assessment of risk throughout quality engineering key processes and systems.
* Provide mentoring to team members to ensure the effective completion of activities associated with their role.
* Assist the quality engineering team lead/quality engineering manager to ensure the appropriate allocation of resources and prioritization of efforts.
* Delegate for the quality engineering team lead/quality engineering manager.
* Ensure that the company's code of conduct is considered in all business matters carried out on behalf of the company.
Qualifications:
* Third-level qualification in science, engineering, or relevant technical discipline.
* Proven knowledge and experience (minimum 4 years at QE level) of working with ISO13485, ISO14971, EU medical device regulation 2017/745, and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
* Excellent communication and interpersonal skills.
* Proven track record of pursuing continuous self-improvement.
* Good working knowledge of Microsoft Office.
* Proven problem-solving skills.
* Taken lead in technical negotiations. Influence others in problem solving/issue resolution.
* Good working knowledge of statistics.
* Knowledge and experience of all aspects of validation.
* Excellent organisational, time management, and presentation skills.
* Excellent attention to detail.
* Proven self-starter.
* Willingness and availability to travel on company business.