At Agilent Technologies, we are seeking a Senior Quality Engineer to join our growing Quality team. In this role, you will be responsible for a broad range of quality assurance activities to ensure compliance with applicable regulatory requirements and standards, such as ISO 13485, MDSAP, and 21 CFR Part 820. You will contribute to the development and continuous improvement of the Quality Management System (QMS), support sustaining quality efforts across departments, and drive operational excellence through the application of Lean Manufacturing and Six Sigma methodologies.
This position involves writing and revising standard operating procedures (SOPs) and other controlled documents, leading investigations, supporting change control processes, and coordinating corrective and preventive actions (CAPAs). You will serve as a quality representative in cross-functional teams, working closely with engineering, manufacturing, procurement, and regulatory functions to ensure quality is integrated throughout the product lifecycle.
Key Responsibilities:
Author, review, and revise quality procedures, quality plans, and controlled documents.
Identify and drive process improvement initiatives, leveraging Lean and Six Sigma tools to reduce waste and enhance product and process quality.
Provide quality support for sustaining and end-of-life product changes including design, labeling, and manufacturing modifications.
Lead or support investigations into nonconformances and customer complaints; develop and implement robust corrective actions.
Participate in and support third-party audits (e.g., FDA, notified bodies, customer audits) and internal audits.
Serve as a Quality Assurance (QA) representative on cross-functional project teams.
Provide subject matter expertise, training, and guidance to internal teams on quality system requirements and best practices.
Review data and approve product batch records and final product release documentation.
Review and approve change orders and risk assessments to ensure regulatory and quality compliance.
May direct the work of vendors, contractors, or external partners to ensure quality-related deliverables are met.
Bachelor’s or Master’s degree in Biology, Chemistry, Biotechnology, Engineering, or a related scientific or technical discipline.
8+ years of experience in the medical device industry, preferably in a regulated environment.
Demonstrated knowledge and practical experience with QMS standards and regulations (ISO 13485, 21 CFR 820, MDSAP).
Experience applying Lean Manufacturing principles and Six Sigma methodology (Green Belt certification preferred).
Strong organizational and analytical skills with a proactive approach to problem-solving.
Excellent verbal and written communication skills; able to communicate effectively at all levels within the organization and with external partners.
Team-oriented with the ability to make sound independent decisions within established guidelines.
Proficient in technical writing, reviewing, and editing controlled documentation.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least May 16, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $119,200.00 - $186,250.00/yr plus eligibility for bonus, stock and benefits. 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/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: 10% of the TimeShift: DayDuration: No End DateJob Function: Quality/RegulatorySimilar Jobs
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