Job Description

Job Title QMS Software Engineer



QMS Software Engineer (Cambridge)

The QMS Software Engineer within our End to End Quality & Regulatory team will apply Philips Quality System Software Controls for NPSS applications across the lifecycle from planning to retirement in line with applicable regulations.

Your role:

• Ensures PEPF/PIL alignment is correct, and PEPF process control requirements are acceptably embedded in related PIL solutions.
• Reviews and approves PIL validation deliverables for consistency against PEPF process definitions.
• Participates directly as the Q&R process automation expert in PEPF programs.
• Defines and establishes a lean practice (tools, methods, standards, competency, process, and process performance) for Software validation & lifecycle control of new and existing SW systems.
• Executes and/or manages software validation & control activities.
• Ensures the accuracy, completeness, and compliance of software validation deliverables by reviewing the software validation packages of software application, which automate quality system processes.
• Authors, reviews and/or approve software validation deliverables for non-product software, including but not limited to software validation plans, requirement test plans/protocols/results, risk assessments, traceability matrix and summary reports.
• Provides guidance/feedback with respect to applicable regulatory requirements and Philips policies and procedures.

You\'re the right fit if:

• You\xe2\x80\x99ve acquired 10+ years of experience in Quality Assurance/Quality Engineering/Quality Systems supporting functional disciplines within a global medical device (pharma) industry. 7+ years of experience in validation of computer systems and systems security and control preferred.
• Your skills include in depth knowledge of quality management systems, working knowledge of appropriate global medical device regulations, requirements, and standards (i.e., 21 CFR parts 803, 806, and 820, ISO 13485 and 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, etc.). Knowledge of worldwide quality system regulations and guidance documents (GPSV/AAMI TIR36 and GAMP 5). You can apply current inspectional techniques to project documentation during the system lifecycles and prior to FDA inspection to ensure a comprehensive documentation package is create and maintained. You are competent in project management and the execution of multiple projects and have a demonstrated capability in critical thinking and leadership.
• You have a bachelor\xe2\x80\x99s degree or higher, preferably in a scientific discipline (technical or engineering or IT related fields). Advanced degrees in Quality, Regulatory, and Software Engineering preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

position. * You possess good analytical skills and process improvement capabilities and can resolve issues of diverse scope by following processes and operational policies in selecting methods and techniques for obtaining solutions. Understand current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections. You have a demonstrated ability to interact and communicate (both oral and written) with junior project team/organizational members, business leaders and senior executives.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won\'t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you\xe2\x80\x99re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Philips Transparency Details

The pay range for this position is $108,472 to $200,256, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found .

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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