SENIOR RELIABILITY ENGINEER

Stryker Corporation; Cork; Hybrid; EUR 50,000 - 70,000; Full time

Job summary

A global medical device company in Ireland seeks a professional to ensure timely closure of product complaint records and oversee investigations. The ideal candidate will lead cross-functional teams and support continuous improvement initiatives. Applicants should have a Bachelor's in Engineering, at least 3 years in the Medical Device Industry, and knowledge of regulatory standards. Excellent problem-solving skills and proficiency in Microsoft Office are essential.

Qualifications

• 3+ years’ experience in the Medical Device Industry, preferably in Post-Market Surveillance.
• Applied knowledge of regulatory requirements: ISO 9001 or ISO 13485.
• Ability to manage and lead complex projects.

Responsibilities

• Ensure timely, accurate, and complete failure investigations of product complaints.
• Organize cross-functional teams for problem identification and product improvement.
• Participate and lead in continuous improvement and process re-engineering.

Skills

Regulatory requirements knowledge

Project management

Verbal communication

Problem-solving

Analytical skills

Education

Bachelor’s Degree in Engineering or related field

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

Work Flexibility: Hybrid**Position Summary**Ensure timely closure of complaint records to comply with FDA and other competent authorities ‘requirements; Monitor key process indicators and make suggestions on areas requiring increased focus to management. Mentor, oversee and approve the work of other team members.## **Key Areas of Responsibility*** Work in a team environment with members of the Post market intelligence group on achieving team metrics requirements.* Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.* Organize a cross functional team to help identify problem issue and drive product improvement process.* Provide support to the new product development and risk management process.* Work with all products, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.* Participate and lead in continuous improvement and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives.* Perform engineering analysis to determine root cause and corrective action.* Attend job-pertinent training classes.**Qualifications/Knowledge/Skills*** Bachelor’s Degree in Engineering or related field of study.* 3+ years’ experience in the Medical Device Industry; preferably in Post-Market Surveillance.* Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive* Demonstrated ability to manage and lead complex or broad scope projects* Demonstrated ability to deliver positive, energetic support to a team, and to be an advocate for product excellence and quality* Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines* Demonstrated verbal, written and interpersonal skills.* Demonstrated problem solving and troubleshooting skills.* Applied knowledge of Microsoft Office software including Excel, Word and Power Point.#IJTravel Percentage: 10%