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Senior Engineer, Design Quality in Singapore, Singapore at SCIEX

Date Posted: 1/21/2019

Job Snapshot

Job Description

Job ID: SCI002888

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.

Sciex offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. 

Sciex is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Join our winning team and Follow us on LinkedIn!


Description

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


This is an individual contributor level role with a great opportunity to gain hands-on experience in global IVD regulations and medical device QMS.

• Participate in new product development initiatives by providing quality engineering support to assigned projects.
• Oversee the Product Development Process and ensure defendable practices and scientific analyses are employed.
• Provide QA oversight on software, hardware and consumable development process throughout the life-cycle of projects to ensure adherence to procedures as required by QMS.
• Collaborate with the software development team to ensure that verification and validation activities are complete and robust
• Perform document review and approval of software, hardware and consumables engineering documentation (e.g. System Requirements Specifications, Design and Development documentation, Verification and Validation Test plans/ procedures /final reports)
• Review and maintain Design History Files and ensure they comply with company procedures and regulatory requirements.
• Participate in Design Transfer activities.
• Participate in supplier selection from design perspective.
• Participate in product Risk Reviews during product development and post-launch activities.
• Maintain product Risk Management files.
• Develop NPI Quality Plans.
• Perform review and approval of Engineering Change Request and Engineering Change Orders.
• Oversee quality procedures for the software, hardware and consumable functions within the Product Development group.
• Lead process definition and improvement activities and training within the software, hardware and consumable functions.
• Provide QA oversight on non-product software validation and perform document review and approval of non-product software validation documentation (e.g. Validation Plan, protocols, Validation Reports)
• Work with the QMS team to improve awareness, communication, and training on quality procedures and initiatives to support corporate quality goals as a leader in Mass Spectrometry as well as an emerging medical device company.
• Provide data analysis & trending of processes & products characteristics and other feedback on current product issues to the development team.
• Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen).
• Member of internal audit team and to lead internal audit teams.
• Mentor and coach individuals and teams while resolving problems and implementing best practices.
• Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.

Supporting Role - Quality Management System (QMS)

• Identify areas for improvement of the QMS through active participation in internal audit program.
• Schedule and support audit activities including pre-audit planning, audit readiness and post-audit follow-up with lead auditor.
• Support the development and administration of the complaints handling, CAPA and internal non-conformance processes.
• Provide training on basic quality tools to the supporting functions.
• Ensure compliance of operations within areas of concern with all relevant EHS regulatory requirements and SCIEX safety policies, procedures and guidelines.
• Any other duties as assigned. 


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Job Requirements



Qualifications

Education and/or Work Experience Requirements:

• Bachelor’s degree in engineering or equivalent.

• A minimum of 5 years of related experience in a manufacturing environment especially instruments manufacturing with focus on

• New product development

• Design changes

• Design transfer

• Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS, ISO 14971 Application of Risk Management to Medical Devices and FDA 21 CFR Part 820 is strongly desirable.

• Exposure to/ experience with verification & validation of medical devices

• Ability to read technical drawings and experience in writing procedures to QMS requirements.

• Excellent writing and oral communication skills with the ability to effectively interface with a variety of associates at various levels.

• Systematic problem-solving skills in identifying, prioritizing, communicating, and resolving quality issues.

• High attention to detail and processes

• Strong organization and multi-tasking skills

• Goal oriented, interpersonal, self-motivated and team player

• Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, DOE, etc.) and their application.

• Certification in Six Sigma green/ black belt is an advantage.

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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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.