Software QA Specialist

The Molecular Devices business unit of MDS Analytical Technologies is known as a world leader for developing innovative, first-to-market products that include instrumentation, software and reagent systems for drug development and life science research products. The products we develop and market help improve the quality of life around the world 

 

PRIMARY FUNCTION:

 

SQA primary function has two major aspects: 1) In an advisory role to software development and product test groups, to identify, through data analysis, how we can improve our processes and provide high quality products to our customers, and 2) Determine, through internal quality audits, if our existing processes are being followed. 

 



Also responsible for participating in customer audits and vendor quality assurance activities.

 

 

RESPONSIBILITIES:

 

Reviews the software requirements, design and test documents.

 

Participates in design review activities.

 

Prepares a SQA Plan to describe all software quality activities for each software development project, and ensures that it is well understood by the Software Development and Product Test A/Cs.

 

Implements the SQA Plan and ensures that all relevant process and project requirements are met.

 

Actively participates in the SQA team meetings and reports status of various projects.

 

Ensures priorities, as set by the SQA Team Leader, and the  SQA schedules are met.

 

Prepares SQA reports on activities conducted.

 

Participates in customer S/W quality audits.

 

Ensures all customer audit nonconformances are addressed in a timely and appropriate manner by responsible persons.

 

Actively participates in the software release review meetings.

 

Reviews the ECN for sign-off and sample checks the integrity of the master software disks prior to their duplication.

 

Ensures that the duplicated software  packages are inspected prior to their delivery to the customers.

 

Monitors SCR database(s) to ensure that reported problems have a satisfactory closure, and/or activities are taking place to resolve outstanding anomalies.

 

Maintains SQA Reports as quality records, in accordance with GQP-016.

 

Conducts internal quality audits and inspections on Software Development and Test activities, when called upon by the Lead Auditor, or as planned.

 

Monitors S/W quality metrics and analyzes data to identify areas for improvement, and in collaboration with software development and product test groups, promotes continuous improvement to processes in place.

 

Assesses the subcontractor's QA and development system for the portion of the software developed outside MDS AT.

 

Prepares SQA A/C Quality Procedures and Work Instructions as necessary.

 

Assists Director, QA & Regulatory Affairs on other quality related issues as necessary.

 

 

QUALIFICATIONS:

 

Bachelor's degree in Computer Science, Chemistry, or other related fields.

 

Previous training on software QA related courses is an asset.

 

At least 5 years of software quality assurance and/or test related experience in high tech industries with R&D, engineering, software development, software test and manufacturing operations, including participation in software audits and inspections.

 

Knowledge of the software development life cycle requirements.

 

Knowledge of the software development, test and QA activities in accordance with ISO 9000-3 International Standard, and TickIT Guide.

 

Familiarity with software development, test and QA activities in accordance with GxP requirements is an asset.

 

Ability to communicate with the third party software developers and testers in ensuring the implementation of quality requirements.

 

 

Knowledge of ISO 9001 Iternational Standard and ISO 9001 based quality system elements and operation.

 

Excellent, clear and concise communications skills.

 

Please go direclty to our website and apply online at  Careers at MDS AT