Company Overview: Our client is a global healthcare leader dedicated to improving lives through innovative medical technologies. With a global presence in over 160 countries, we provide solutions ranging from diagnostics to medical devices, offering transformative products that aid in patient care decision-making across various health conditions.
Job Summary: We are seeking a Quality Engineer II to join our team in Puerto Rico. The Manufacturing Quality Engineer will be responsible for ensuring the highest quality standards for manufacturing products in the product portfolio. This role plays a pivotal part in ensuring the quality and compliance of our medical devices team, working closely with cross-functional teams to maintain adherence to regulatory and quality requirements and industry standards. The successful candidate will leverage their expertise in quality assurance and manufacturing engineering to drive continuous improvement initiatives and uphold the highest standards of product quality.
Key Responsibilities:
- Collaborate with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with LifeScan software development procedures and industry regulations.
- Provide expertise in troubleshooting and resolving technical issues with equipment.
- Conduct all verification and validation activities for a new site.
- Handle IQ, OQ, PQ protocol generation and execution, deviations and reports generation.
- Assist teams in developing tailored Standard Operating Procedures and Work Instructions
Qualifications:
- Bachelor's degree in Engineering required,
- 3-5 years of experience in Engineering, preferably within the medical device manufacturing industry.
- Strong attention to detail and ability to manage regulatory compliance and reporting requirements.
- Strong background in V&V activities
- Knowledge of FDA Quality System Regulation, ISO13485, and other international standards.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.
- Proven ability to lead and drive quality improvement initiatives in a dynamic environment.
This job will be reviewed periodically and is subject to change by management.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.