Job Description
A Manufacturing Compliance (Quality and Regulatory) Engineer ensures that all manufacturing activities comply with relevant ISO standards and regulatory requirements. This involves conducting audits, analyzing data, reviewing documents, and making decisions about product disposition.
Principle Duties/Responsibilities:Develop and Revise Quality Management System (QMS) Processes and Procedures: Write and update QMS processes and quality-related procedures as needed.
Implement and Maintain QMS: Ensure the effective implementation and maintenance of the QMS concerning change notices/orders, investigations, and corrective/preventive actions.
Coordinate Across Departments: Collaborate with manufacturing, R&D, field operations, and marketing teams globally to ensure that necessary changes, investigations, and corrective/preventive actions are executed effectively.
Provide Timely Updates on Quality Issues: Regularly update and follow up on the status of all assigned changes, investigations, and corrective/preventive actions.
Data Collection and Analysis: Gather and analyze data using appropriate statistical tools to support quality initiatives.
Identify and Oversee Improvement Initiatives: Recognize opportunities for improvement, recommend actions, and oversee their implementation.
Familiarity with Process Validation: Have a solid understanding of process validation and instrument qualification procedures.
Collaborate with Engineering Team: Work alongside the engineering team to ensure that device conformity is thoroughly assessed prior to release, while also maintaining Technical Documentation/files and Declarations of Conformity.
Participate in Quality Training Programs: Engage in the Quality Training program by developing and enhancing training materials, as well as conducting training sessions for both new hires and existing employees.
Facilitate Quality Audits: Organize and facilitate both internal and external quality audits to ensure compliance with standards.
QualificationsEducational Background: A Bachelor's or Master's Degree, or an equivalent university qualification.
Experience Requirement: A minimum of 2 to 4 years of relevant professional experience.
Knowledge of Quality Standards: Familiarity with Quality System Standards such as ISO 9001:2015, ISO 13485:2016, FDA CFR 21 Part 820, IEC 61010 as well as regulations related to In Vitro Diagnostics (IVD) and Medical Devices in the EU/US; familiarity with EMC and CSA safety compliance is an added advantage.
Data Analysis Skills: Proficient in data analysis, statistical tools, root cause analysis, and problem-solving, with a strong mindset focused on continuous improvement (CI).
Language Proficiency: Fluent in English, with strong writing and verbal communication skills.
Encouragement for New Graduates: Recent graduates with relevant internship experience in Quality Management Systems (QMS) and a strong interest in quality engineering and regulatory affairs are also encouraged to apply.
Additional DetailsThis job has a full-time weekly schedule.
Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:https://careers.agilent.com/locations
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:Occasional
Shift:Day
Duration:No End Date
Job Function:Quality/Regulatory#J-18808-Ljbffr