Senior Quality Engineer
Job TitleSenior Quality Engineer
Senior Quality Engineer
In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
The Senior Quality Engineer will play a key role in creating, establishing, and supporting site Quality Engineering and Regulatory program functions in support of Engineering, Production, Regulatory and ISO guidance's including, but not limited to development and continuous improvement of quality system processes and documentation, providing design and development/sustaining support through quality and regulatory planning, management and execution of plans, complaint handling, root cause analysis, and quality auditing, both internal and external. Must participate on QA teams to resolve quality problems, enhance existing programs, and support a continuous improvement culture. Will be required to represent Quality Assurance on new product development and sustaining teams or in standing meetings to address quality issues that maybe raised and to provide QA support. Must participate in risk analysis methodologies and health hazard evaluations as required. Must assist Production and Materials groups with materials review of nonconforming materials and processing of materials for return/corrective action. Other responsibilities include the creation of operating instructions, review and approval of Quality System Procedures, validation reports, and review and approval of engineering change notices. Must additionally lead/participate on internal audit teams in conducting internal quality system audits, external supplier development/audit including periodic supplier assessments, review production line failures and recommend and own Corrective and Preventive Actions as appropriate.
You are responsible for
The responsibility of this position will be to maintain and improve Quality Engineering Programs and Quality System activities to enhance the quality of products and services we supply. The QE will be knowledgeable in all areas of the Quality Management Systems. In addition to the Quality Program/System responsibilities, QE is expected to support new product development and sustaining engineering directly as part of a project team or indirectly for peripheral support needs. This position supports and guides product development teams through the design life cycle and transfer of the product into manufacturing and post manufacturing support ensuring compliance with the Quality System Regulations, 21 CFR Part 820, ISO 13485 and other international standards. In addition, the successful candidate will be responsible for post market activities associated with that product line including any sustaining activities and contract manufacturing production issues. The Senior Quality Engineer is viewed as an active and valued contributor to design, risk analysis, project plan, process validation, and design transfer activities. The Senior Quality Engineer is required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase. Conduct safety, efficacy and hazard analysis, FMEAs, FTAs and FTA Criticality and help to drive improvement in Quality Metrics such as product development cycle time. The Sr. QE will conduct internal quality system audits and external audits, lead process auditors in process audits and record audits, review production line failures and corrective actions, review and investigate customer complaints conduct quality system training, write and review procedures for quality assurance and other functional elements of the quality system and resolve corrective and preventive action (CAPA) issues. The Sr. QE will also work with suppliers to resolve product/process issues, monitor supplier performance and conduct supplier audits.
- Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device development & testing, including CFRs, ISO, MDD, and other international/regulatory standards.
- Excellent technical writing, communication, and organization skills and working within FDA or similarly regulated environment, required.
- Plans and manages assignments of significant technical scope
- Perform technical and non-technical product failure evaluations documenting and effectively communicating root cause findings.
- Skilled at performing reviews, system/product failure analysis, First Article Inspections (FAI), and Incoming Inspections, as required.
- Skilled in creating, interpreting and modifying component/schematic drawings.
- Support new product development and product engineering by generating and/or processing key documents which may include quality plans, design review, risk and hazard analysis, verification and validation plans, product and process validation.
- Conducts internal quality system audits and external audits.
- Willingness to work as part of a team and strong verbal and written communication skills are essential.
- Able to work independently and complete multiple assignments on time.
- Skilled with applying Quality Tools.
- Skilled in Internal Auditing and Lead Auditor duties.
- Capable of making technical calculations involving the use of engineering and mathematical formulas such as finding standard deviations.
- Skilled at trouble shooting and problem solving.
- Skilled at interacting directly with suppliers, operation/manufacturing services and engineering support services.
- Understanding Software Validation is preferred.
- Skilled with Word or other word processing software, and SAP (or related) navigation, required. Experiences with multiple statistical/QS software packages are a plus.
- Write routine procedures and reports and make necessary corrections.
- Write and update Quality Inspection Plans.
To succeed in this role, you should have the following skills and experience
- Candidate must have a minimum of 7 years experience working in a Quality Engineering role.
- Experience in an ISO registered and regulated industry is required.
- BSEE preferred, BS Engineering field required
- Position functions in a standard office environment requiring periods of time sitting, standing and walking. Must be able to use computer interface equipment and other standard technologies such as terminals, PCs, printers, copiers, fax machines and telephone systems. May occasionally need to lift and move products.
In return, we offer you
A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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. 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 on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
Find out more info about Philips at www.philips.com/na/careers
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.
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