Quality Engineering Specialist in Concord, Ontario at SCIEX

Date Posted: 7/8/2018

Job Snapshot

Job Description

Job ID: SCI002233

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

The Quality Engineering Specialist is an exciting opportunity that will allow a successful candidate to grow in the area of Quality within the IVD marketplace.  The position will support a variety of areas within the Quality Management System. This candidate will oversee Design Control, Risk Management, and Quality Systems activities.   The candidate will work closely with the Development team located at AB SCIEX in Concord, Ontario. This is a position that requires a qualified candidate with strong experience implementing and maintaining quality management systems in the medical device industry.

RESPONSIBILITIES:
•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 the design perspective
•Participate in product Risk Reviews during product development and post-launch activities
•Maintain product Risk Management files.
•Develop Quality Plans
•Assist or lead internal audits and support external audits
•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.
•This is an individual contributor level role with a great opportunity to gain hands-on experience in global IVD regulations and medical device QMS


#LI-SL1.

Job Requirements



Qualifications

QUALIFICATIONS:
•Bachelor's degree in a scientific or engineering discipline (mechanical, electrical, chemical or biological expertise preferable) from four-year college or university and/or training or equivalent combination of education and experience
•Post graduate certification or training in Quality Assurance preferable but not required
•ASQ CQE certification is preferable but not required
•5-10 years QA experience of implementing and maintaining ISO 13485:2003 (21 CFR Part 820 QMS preferable)
•Familiarity with IVD regulations in the USA, Canada, Europe
•Familiarity with ISO 14971 standard (familiarity with IEC 62304 is an asset)
•Familiarity with 21 CFR Part 11 regulation
•ISO 13485 or ISO 9001 auditor experience is required
•ISO 13485 Lead Auditor certification is preferable but not required
•Experience in Risk Management as it relates to Medical Devices products and processes
•Exposure to and/or experience with verification and validation of Medical Devices e is required
•Experience in QMS documentation writing and review
•Experience in the use and application of quality tools, process improvement and info-mapping tools
•Systematic problem-solving skills in identifying, prioritizing, communicating, and resolving quality issues.
•High attention to detail and processes
•Strong interpersonal skills and ability to work in a cross-functional team environment, as part of a global company
•Strong organization and multi-tasking skills
•Strong communication skills (written and verbal)
•Strong personal computer skills (e.g. Microsoft Office Suite) 









SCIEX is an equal opportunity employer, and only those candidates who are qualified will be contacted.  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.


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.