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Engineer I/II, QARA in Singapore, Singapore at SCIEX

Date Posted: 4/25/2019

Job Snapshot

Job Description

Job ID: SCI003235

About Us

SCIEX – An operating company within Danaher’s Life Sciences platform
SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. Our leadership in LC-MS and CE-MS have made us a trusted partner globally to those who are focused on basic research, drug discovery, food and environmental testing, forensic toxicology, clinical research and diagnostics. With over 40 years of innovation, we continue to redefine what is achievable in routine and complex analysis.
We are seeking smart, team-oriented people who have purpose and are committed to helping us deliver Answers for Science. Knowledge for Life. ™ Our global team, located on every continent, is our greatest strength, bringing diverse perspectives and breakthrough thinking. With the power of the Danaher Business System behind us, it’s our people who have made us the industry leader. Come join our winning team. Visit us at www.sciex.com.


Description

We are looking for great talent, for future opportunities.   This is an evergreen / pipeline position, to help us proactively identify potential candidates for future openings.

Essential Duties, Critical Success Factors, Responsibilities, Authorities and Required Interactions:

• Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.
• Participate and lead cross-functional teams working on key company initiatives.
• Track, report, & improve key quality indicators for compliance and efficiency.
• Identify, report, and seek correction for deviations noted in workplace. Embrace a behavior of employee involvement and commitment to doing the job right the first time.
• Act as lead quality auditor for quality audits, including development of audit plans, managing audit teams. Periodically lead or provide technical support to a variety of audit needs (e.g., compliance, supplier, audit readiness).
• Support audit activities including pre-audit planning, audit readiness and post-audit follow-up with external auditor.
• Mentor and coach individuals and teams while resolving problems and implementing best practices.
• Drive closure of NCMRs, Issues, CAPAs and Audit action items related to QMS and compliance issues. Work with cross functional department to ensure that issues are addressed & closed in a timely manner.
• Author, review and/or approve documentation as required (Standard Operating Procedures (SOPs), applicable deviation reports for equipment and process related deviations, etc).
• Support the development and administration of Deviation, Issue, Doc Control and Calibration
• Establish and provide QMS related training base on schedule (e.g. New Hire Induction, QMS refresher, Doc Control, Issues Deviation etc.)
• Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen).
• Pro-actively improve quality systems to support manufacturing including reviews across all areas of operations to ensure a level of consistency and standardization in AB Sciex QMS.
• Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements on an ongoing basis.
• Ensure compliance of operations within area of concern with all relevant EHS regulatory requirement and SCIEX safety policies, procedures and guidelines.
• Other duties/ ad hoc tasks as assigned.

Supporting Role:

Document Control

• Ensure that all document changes generated (via DCRs) are compliant to internal procedures and are being reviewed and approved by all appropriate functions.
• Manage Document Control in the company/ maintain the full control of document per Quality Management System
• Establish and enhance existing work instructions and procedures.

Calibration

• Manage the calibration system by maintaining the Inspection, Measuring and Test Equipment and ensure required instruments are duly calibrated.
• Establish and enhance existing work instructions and procedures.
• Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen).

Additional Requirements:

• Excellent writing and oral communication skills with the ability to effectively interface with a variety of associates at various levels.
• Detail oriented with Good organizational and time management skills
• Able to work independently
• Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, DOE, etc.) and their application.

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Job Requirements



Qualifications

Education and/or Work Experience Requirements:

• Bachelor’s degree in engineering or equivalent.
• A minimum of 3 years of related experience in a manufacturing environment especially instruments manufacturing.
• Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desirable.
• Experience in conducting/ leading QMS audits.
• Experience in handling document control management program (EDMS) and calibration program.
• Experience in writing procedures to QMS requirements.

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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.