- Collaborate with affected stakeholders to understand validation needs, and to develop validation plans for new products and existing processes.
- Work with affected stakeholders to identify validation issues with the goal of continual improvement.
- Analyze, derive, and allocate validation requirements, budgets, and targets for validations.
- Facilitate and participate in Failure Mode and Effects Analysis (FMEA) of processes to drive reliable NPI and improve validation/verification test planning.
- Provide input for validation requirements based on NPI review.
- Develop validations strategies based on the QMS.
- Develop and/or manage validation guidelines and apply lessons learned to enable continual improvement.
- Create and maintain process validation plans and reports.
- Manage and/or perform statistical data analysis following best practice/industry guidelines.
- Coach engineers on the required validation activities, drive learning and meet project milestones.
- Provides information to Risk Management anticipating validation-related safety hazards.
- Work with supplier selection for high quality starting stock and provide clear guidance on validation requirements for suppliers.
- May include limited travel requirements, up to 20% of the time.
- Certified ASQ Quality Engineer and/or bachelor's degree in Engineering, Science, or technical discipline with 7+ years of quality, manufacturing, or other technical experience OR Advanced degree Engineering, Science, or technical discipline with 5+ years of quality, manufacturing, or other technical experience
- Demonstrated ability to perform effective validations in an ISO 13485/ 21 CFR environment
- Proficient in data analytics, industrial statistics, (preferably using MiniTab)
- Demonstrated ability to provide effective internal and external communication
- Demonstrated ability to provide clear, concise written reports to internal and external customers
- Demonstrated project management ability
- 2-4 years' experience in a job shop environment, preferably servicing the Medical Device Industry
- Lean Six Sigma Green Belt (Black Belt preferred)
- Proficient in Microsoft Office Suite
- Working knowledge in progressive management technologies such as Lean Manufacturing, JIT, MRP, and ERP - Desired
- Ability to travel up to 20% of the time - Desired
- Ability to communicate effectively in English and Spanish - Desired
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Quality & Validation Engineer - San Diego, United States - Johnson Matthey
Description
Pay Range: $$ $$105000
Together for a cleaner, healthier world.
Johnson Matthey, a FTSE 250 organization, is a global leader in sustainable technologies specializing in catalysis, precious metal products, chemicals and process technology. With operations in over 30 countries, we employ more than 12,600 people. We have more 200 years of success behind us; be part of the next stage of our growth journey and help maintain our reputation as one of the most admired organizations in our field. Our unique culture and people give us competitive advantage and will ensure our success for years to come. You can be part of that success story.
This position is responsible for leading site-wide process validations to assure compliance to Company, Customer, and ISO requirements. The Quality & Validation Engineer is responsible for directing and/or implementing validations and improvements on new and existing process often working with cross-functional team members (NPI, Quality Engineering, Manufacturing, Supply Chain and Sales/Marketing) focusing on the reliability of new and existing processes from NPI through production and delivery.
Your responsibilities:
We offer a competitive compensation and JM Elements benefits package including bonus, excellent pension contributions and 20 days annual leave (varies for shift- based roles). Our JM Elements Benefits programme helps our employees understand and manage the JM benefits, as well as helping you focus on your overall wellbeing - for you and your family. We use our inspiring science and technology to enhance lives. For those who are passionate about sustainable solutions and shaping our markets, we offer stretch and a wealth of diverse opportunities. We'll give you freedom to bring your whole self to work and be part of a team where difference matters and all voices are heard, that genuinely cares for you and where your contribution is appreciated. We'll empower you to lean in and make things happen, to create solutions and value for our customers. United by our values and vision, we're self-starters sharing the same values and accountability and always with a shared commitment to doing the right thing. We're passionate about making a difference and delivering a better tomorrow for us and for you - a cleaner and healthier world, today and for future generations.
Johnson Matthey is open for discussion on job share and flexible working patterns.
How to apply:
If you have the necessary skills and experience to join our team, please apply online. For any queries or should you require any reasonable adjustments to support your application please let your recruiter know when they contact you.
If you are already a Johnson Matthey Employee, please visit the internal careers site to apply: Find Jobs - Workday )
All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Johnson Matthey for the selection of suitable candidates for our vacancies as they arise. Johnson Matthey respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice: Johnson Matthey Privacy Notice
You will be contacted by the Johnson Matthey Talent Acquisition team once your details have been reviewed. Please allow four weeks from the closing date to allow for screening to take place.
We appreciate the time and effort taken in completing an application.
By applying for this role and creating an account you are agreeing to Johnson Matthey Privacy Notice
Johnson Matthey Plc is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
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