Philips Senior Quality Assurance Engineer in Gainesville, Florida
This position is responsible for driving improvements in the quality system. The position is also responsible for partnering with Philips Healthcare in developing common/harmonized QS procedures (where appropriate) as well as working across the MR business unit to ensure common/harmonized QS procedures (where appropriate).
This position will lead the quality system function to ensure quality system activities are in compliance with FDA’s Quality System Regulation, ISO 13485, MDD, MHLW and all other applicable requirements.
Additionally, this position will develop, establish and maintain quality system programs, architecture, content, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction.
This position requires strong communication, partnering and relationship building cross-functionally within the Invivo sites, MR business and across Philips Healthcare.
• Lead Quality System-driven initiatives to drive change to continually improve our effort in delivering the highest quality products, with supporting tools and processes, to our customers in a timely manner.
• Lead the Quality Systems area to ensure quality system development and compliance with corporate policies, FDA’s QSRs, CMDR, ISO 13485, MDD and other quality requirements, regulations and guidelines. Responsible for managing external (FDA, Notified Body, etc.) and coordinating OEM and Corporate internal quality and compliance audits of the quality systems.
• Manages on-site external audits for the site.
• Coordinate and lead management review process.
• Contribute quality systems expertise to assist in continuous improvement activities throughout the organization.
• Performs other related duties as assigned.
• Bachelor’s Degree in Engineering or Science related field
• Minimum of 4 years’ related experience in engineering and/or quality assurance in a regulated industry
• Demonstration of a willingness and ability to institute change.
• Fluency in GMP and MDD regulations
• Demonstrated knowledge of 21 CFR 820, ISO 13485 and ISO 14971 and related regulations.
• Proven leadership skills including influence management:
Proven project management skills
Solid judgment and problem solving skills
• Experience leading a project.
• Experience in an electronic manufacturing environment
• Strong oral/ written communication skills and interpersonal skills.
• Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures.
• Ability to perform work without appreciable direction.
• Ability to represent the department in frequent inter-organizational contacts.
• Ability to effectively manage/participate in multiple projects / programs.
• Excellent knowledge of Imaging System Devices.
• Self-starter and accountable, with sharp focus on quality and customer experience.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
May require domestic travel up to 10% of the time.
In this role, you have the opportunity to
Serve as subject matter expert (SME) for Quality Systems, train, coach and mentor other employees on the system, process and tools.
You are responsible for
Facilitating validation oversight for Non Product Software implemented / to be implemented to ensure risk is addressed and validation status is tracked and maintained.
Collaborating with project / program teams to ensure work products comply with Philips Invivo procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
Accumulating / Consolidating / Analyzing data relevant to Quality Systems monitoring and metrics communicated to management through Management Reviews, Routine Metrics / Key Performance Indicators (KPI), Product Qualification reviews, and Phase Approval reviews.
Providing guidance and direction to other Q&R and technical support staff on Quality System.
Driving SOP updates or creation of new processes based upon upcoming standards or process improvements.
Applying and improving advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.
Working under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated.
Determining and pursuing courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
Working closely with business functions (Operations, R&D, Quality, Regulatory, Clinical) to continuously improve the Quality Systems process.
To succeed in this role, you should have the following skills and experience
Bachelor’s Degree in Engineering or Science related fieldCertification in Quality Systems (e.g. CQE, CQM, Lead Auditor)
Minimum of 7 years’ related experience in Quality Systems in a regulated industry
Working knowledge of ISO 13485, ISO 14971, and 21 CFR 820, 21 CFR Part 11
Hands-on experience in software validation and risk management tools (FMEA, or Risk Analysis, etc.)
Working knowledge of Validation and Verification, Risk Management, Management Review, CAPA, and Design Controls
Working Experience in the development implementation and improvement to Quality Management Systems in a Medical Device Environment
Working knowledge of IEC 60601-1 and MDD requirements and various medical industry standards
Experience in an electronic manufacturing environment
Strong oral/ written communication skills and interpersonal skills
Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures
Ability to present proposals, data, and issues to Invivo personnel at all levels
Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives
Ability to perform work without appreciable direction
Ability to effectively manage/participate in multiple projects / programs
Knowledge of Imaging System Devices
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.