Principal quality engineer job description

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As we continue to grow, we are seeking a Principal Quality Engineer who will provide Quality Engineering leadership at our Memphis Distribution Center. This position is located in Memphis, TN.

The Responsibilities

Ensure the effective management of non-conforming product, ensuring adequate segregation and material controls are in place. Manage the overall Material Review Process and ensures timely disposition and as necessary destruction of product including provision of objective evidence through issuance of certificates of destruction.Manage the CAPA portfolio at the Memphis Distribution Center. Lead the deployment of industry best practice problem solving tools (including but not limited to Process Excellence tools) to drive rigor in the identification of root cause at the Distribution Center. Following risk level determination, drive to robust corrective and preventative actions and ensure that CAPA effectivity is assessed at the site utilizing appropriate statistical methodologies. Chair's the Site Intermediate Quality Review Board (IQRB) ensuring quality system records are maintained and progressed to closure per timeliness defined within the governing procedures.Develop and maintain the Site Master Validation Plan ensuring all necessary facility infrastructure, equipment, pack-outs and shipping lanes are maintained in a validated state. Participate in the validation process as a subject matter expert (SME) and approves validation protocols and reports as the quality representative. Ensure that periodic reviews are conducted, and revalidation is performed at the necessary frequency or as required following the assessment within the Change Management process.Support the administration of the Change Control Process at the Memphis Distribution Center. Ensure that changes are adequately scoped, actions are executed, objective evidence is provided and the timeliness of change implementation. As necessary, deputizes for the Quality Site lead as the Change Implementation Board (CIB) Chair.Act as a subject matter expert (SME) and partner with key stakeholders and business partners across the organization. Provide coaching, mentoring and training to associates at the Memphis site in Quality Engineering and Validation principles and techniques.Support the implementation and maintenance of the Quality Management System at the Memphis Distribution Center and participates in both Internal and External Quality Management System inspections. Partner with Global Compliance to identify and mitigate compliance risks at the Memphis Site.Participate in audits and inspections of the facility as a co-host and/or subject matter expert (SME).

The Individual

Bachelor's degree in Science, Engineering, QA, or other related business field with a minimum of 7 years of supply chain/distribution experience in the medical device, biologics or pharmaceutical environment is required.Broad based technical knowledge and competency within Quality Engineering, Quality Assurance and Quality Systems allied with a good working knowledge of operations and/or supply chain environment in the medical device or pharma sector.Experience and knowledge associated with specific Quality System Regulations, standards and directives required including FDA/Quality System Regulation, 21 CFR Part 820, ISO13485:2016 is required.Ability to effectively negotiate and influence business stakeholders and other departments is a required.Strong critical thinking and decision-making skills with an ability to provide innovative solutions within the boundaries of the quality and compliance environment in which the business operates within.Strong conflict resolution and change management skills Strong written and verbal communication skills.Strong analytical reasoning skills Demonstrated ability to work in a diverse, cross-functional environment.Experience hosting and/or participation in quality management system audits is preferred.Knowledge of State Board of Pharmacy requirements and National Association of Board of Pharmacy (NABP) Accreditation preferred.Demonstrated knowledge of business impact of compliance issues and risk management is desirable.ASQ certification is desirable.

EOE/AA Disability/Veteran

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As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status.

As a Principal Quality Engineer, you recognized across the organization for functional expertise. Conducts highly complex quality assurance tests and analysis to ensure that software meets or exceeds specified standards and end-user requirements. Performs technically advanced or in-depth development and execution of test cases. Works closely with Project Management, Quality Assurance, and Development teams on multiple, multi-faceted projects from creation to completion. We are seeking talented Information Technology professionals to join the Waste Management team who are motivated to help us transform the way we design, build and use technology. With your skills and experience, we look for you to combine your technical expertise with industry best practices to align information technology solutions with Waste Management business strategy.
Essential Duties and Responsibilities

* Participates in agile ceremonies and leads agile QE teams in an enterprise environment.
* Assigns and oversees QE team assignments and generate project health reports.
* Authors test cases, scenarios using Jira, Zephyr, HP ALM
* Automates and executes test cases using open-source automation frameworks like Selenium using Java.
* Identifies test requirements from product specifications.
* Displays clear, concise detail-oriented test plans and use cases.
* Partners with project team, understanding requirements, design, and test script scenarios.
* Performs standalone and integration testing with internal IT applications.
* Identifies application issues during testing and works with project teams to determine solutions.
* Creates test data with valid and invalid records to thoroughly test application logic and verify system flow with internal applications.
* Manages complex or ambiguous quality assurance issues and works with internal IT staff to determine resolutions.
* Drafts and revises complex testing documentation (including plans, conditions, and scripts).
* Executes advanced tests according to established plans and scripts, documents problems in an issue log, and retests software corrections to ensure problems are resolved.
* Plans and schedules user acceptance and alpha and beta testing schedules.
* Creates test data files with valid and invalid records to thoroughly test program logic and verify system flow.
* Applies knowledge and understanding of the Software Development Life Cycle (SDLC).

Supervisory Responsibilities

Coach and mentor less-experienced analysts and function as team leader on more complex system projects.

Qualifications

The requirements listed below are representative of the qualifications necessary to perform the job.

A. Education and Experience

* Bachelor's Degree (accredited) in Computer Science, MIS, or similar area of study, or in lieu of degree, High School Diploma or GED and four (4) years of relevant work experience.
* Ten (10) years of previous experience required.

B. Other Preferred Experience

* 10 years of Quality Assurance, QA Engineering, or SDET positions.
* JIRA software processes and procedures.
* Quick Test Pro (QTP) automation
* Query Surge ETL test automation tool
* Query tools such as SQL and Toad
* logistical applications like OCS, DA and Mobile native & web-based applications

Work Environment

Listed below are key points regarding environmental demands and work environment of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

* Normal setting for this job is an office setting.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Your Role at Baxter

The Principal Engineer will provide Quality Leadership for Monitoring and Sensing products both New Product Development (NPD) and post market support. You will apply diversified knowledge of engineering and quality principles to ensure compliance to medical device regulations and continuously improve product performance.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

• Responsible for implementing Baxter quality policies by partnering with Commercial, R&D, Regulatory, and other functions to develop and execute Quality strategies aligned with product development, change control, and post market initiatives.
• Plans, schedules, and leads multi-functional team in detailed phases of the Quality work on project initiatives.
• Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints, Maude) to drive decisions.
• Develops product coding and establishes thresholds for product post market surveillance systems.
• Serves as a mentor, trainer & supports development of more junior associates.
• Supports Quality internal and external audits. Serves as an internal auditor if required.
  

What you'll bring

• Bachelor’s degree in engineering is required.
• Master’s degree is preferred.
• 5+ years of proven experience in Quality Engineering.
• A solid understanding of US Code of Federal Regulations, EU regulations, and ISO standards.
• Critical thinking skills in the application of Quality Management System concepts with a focus on executing design control across the Product Development Lifecycle.
• Ability to navigate in an abstract development environment applying agile development methodologies to advance quality deliverables concurrent with design maturity.
• Experience working with multi-functional teams, including technical/non-technical work.
• Proven leadership skills and ability to work independently.
• Ability to organize and present technical information with minimal assistance.
• Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
• Strong oral and written communication skills.
  

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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