Description
Job Posting Start Date 08-23-2024 Job Posting End DateFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Validation Quality Manager in Austin, TX
Reporting to the Quality Manager, the Validation Quality Manager will be responsible for supervising a team of process & facilities validation / quality engineers to ensure that the equipment and facilities used for medical device manufacturing process are appropriately developed, validated to meet Flex's internal policies, procedures and regulatory requirements.
Here is a glimpse of what you'll do:
Guide and support the validation team, provide validation and QA oversight on process / facilities validation and qualification activities to ensure compliance and recommend appropriate corrective actions as needed.
Assure validation policies and procedures are implemented and followed for medical device manufacturing.
Implements and coordinates product assurance program to prevent or eliminate defects in new or existing products.
Researches, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.
Suggests, debates alternative methods and procedures in solving problems to meet business needs and changing market opportunities.
Collaborate with other management personnel in formulating and establishing company policies, operating procedures and goals.
Develops initial and subsequent modifications of product assurance program to delineate areas of control, personnel requirements and operational procedures within program.
Interface with customers on technical/quality issues and improvement initiatives.
Responsible for managing regulatory/compliance agency/customer audits by acting as an SME for the respective area / business process.
Reviews technical problems and procedures and recommends solutions to improve and streamline the existing quality system processes.
Implement practices around validation controls for all manufacturing areas in line with applicable policies and procedures.
Executes and manages validation and control activities by authoring, reviews, and approving validation deliverables, including but not limited to validation plans, requirement test plans/protocols/results, risk assessments, traceability matrices, and summary reports.
Monitor validation deliverables and activities for assigned area to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
Additionally required to support other areas of validation as deemed necessary by business.
Here is some of what you'll need (required):
Typically requires a Bachelor's degree in Engineering or related field or equivalent experience and training
6 years of quality/ validation experience
Prior process and/or facilities validation experience working in medical device, pharmaceutical or biotechnology industry with understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001.
Working knowledge of process, facilities validations and GAMP standards.
Experience in generating, review and approval of validation deliverables, statistical analysis, risk management, incident and change management.
Experience in a prior quality assurance role and ability to work independently with minimal supervision.
Excellent communication, organizational, project management and decision-making skills.
Prior supervisory, project management or software validation experience is a plus.
Experience working in 24/7 operations environment strongly preferred.
Here are a few examples of what you'll get for the great work you provide:
Full range of medical benefits, dental, vision
Life Insurance
Matching 401K
PTO
Tuition Reimbursement
Employee discounts at local retailers
Is Sponsorship Available?
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).Apply on company website
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