Global Quality Systems Engineer

4 weeks ago

Johor Bahru, Malaysia PerkinElmer Full time

The Company

PerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and management and today complements its service offerings with a broad portfolio of atomic spectroscopy, molecular spectroscopy, and chromatography instruments, consumables, and reagents. With a dedicated team of more than 5,000 team members, the Company serves customers in more than 35 countries. Additional information is available at www.perkinelmer.com

Purpose

Support the Quality Systems and Operations Leader to execute the QMS and drive key performance indicators across the business. The primary responsibility is to provide global support to address any complaints that arise from customer feedback, support training administration, support document control, and support the measuring and monitoring of local and global metrics. Additional duties include supporting product quality related responsibilities and projects (maximum 40% of week).

Responsibilities

Demonstrate knowledge and adherence to site safety requirementsExecute goals and strategy for corporate level actives based upon company’s business objectivesCoordinate global customer complaint activities across multiple sites which includes activities such as risk assessment, escalation, investigation, communication, and metrics maintenanceManage controlled documentation, training material, presentations, metrics, records - including retention and destructionSupport a QMS, including eDMS management, audit program support, change control process execution and training material developmentCollaborate as appropriate in site processes, procedures, and work instructionsPerform other duties necessary for the effective operation of the QMS

Basic Qualifications

2+ years of experience as a Quality Associate or equivalentDemonstrating strong attention to detail and technical writingUnderstanding root cause analysis and Quality tools as CAPA and change controlParticipating in Management Review and its activities as compiling data, trend analysis, inputs or addressing any resulting actionsSupporting the audit process and contributing to any external audits, as necessary

Preferred Characteristics

Preferred Characteristics

Experienced in a Quality Management System in a manufacturing environment, preferably ISO 9001:2015Strong knowledge and its application in ISO 9001:2015 and the complaint handling process2-5 years of experience as a Quality Systems Specialist or equivalentExperienced in an electronic document management system (eDMS) and training for multiple sites or applicationsTrained as an internal auditor and supporting key customer auditsStrong interpersonal, verbal, and written communication skills, and developing strong collaboration with site leadership

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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