Job Title: Quality Engineer
Job Description:
This is a quality engineer role that involves providing technical leadership within Quality Engineering to support various teams. The primary function of this role is to provide technical guidance and support to production, quality control, purchasing, facilities, IT, regulatory, analytical lab, research and development, and engineering sustaining teams.
The role includes providing support for process validation, change requests, non-conforming product issues, corrective and preventive action program, design and process FMEA, risk assessment, and associated quality system documentation.
The quality engineer will drive all assigned quality engineering projects and ensure they are managed in a structured fashion and completed in compliance with relevant procedures.
They will manage and drive project activities to ensure timely completion of project milestones, represent the team at key review meetings, and work closely with other functions to build effective relationships.
The quality engineer will lead in the area of FDA, QSR, and ISO 13485 requirements, promoting awareness of best industry practices and making appropriate decisions on a daily basis.
They will identify and implement opportunities for improvement and implement them under their own initiative.
Maintaining a proactive approach to developing Cook's quality system to meet the changing needs of the business is essential.
Ensuring that in-house or external quality issues are effectively prioritized and acted upon in a timely manner is also critical.
The quality engineer will demonstrate proven experience and proficiency across functional areas such as design, process, risk management, software validation, supplier quality, CAPA, non-conformances, customer complaints, sterilization, statistics, facilities/environment, microbiology/biocompatibility, and 6 Sigma/Lean/Continuous Improvement.
Required Skills and Qualifications:
* Third-level qualification in science, engineering, or relevant technical discipline.
* Proven knowledge and experience (minimum 4 years at QE level) of working with ISO 13485, ISO 14971, EU Medical Device Regulation 2017/745, and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
* 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 organizational, time management, and presentation skills.
* Excellent attention to detail.
Benefits:
This role offers a challenging and rewarding career opportunity for a quality engineer who wants to make a significant impact in the medical device industry.
As a quality engineer at Cook Medical, you will have the opportunity to work on a variety of projects and contribute to the development of quality systems and processes.
You will also have the chance to collaborate with cross-functional teams and develop your leadership and technical skills.
Others:
To be considered for this role, you must have a third-level qualification in science, engineering, or a relevant technical discipline.
Applicants must also have a minimum of 4 years of experience at QE level and proven knowledge and experience of working with ISO 13485, ISO 14971, EU Medical Device Regulation 2017/745, and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
Excellent communication and interpersonal skills are essential, as well as a proven track record of pursuing continuous self-improvement.
A good working knowledge of Microsoft Office and proven problem-solving skills are also required.
Applicants should have taken lead in technical negotiations and influenced others in problem-solving/issue resolution.
Good working knowledge of statistics and knowledge and experience of all aspects of validation are also necessary.
Finally, applicants should have excellent organizational, time management, and presentation skills, as well as excellent attention to detail.