Quality systems engineer job description

Rocket Lab is a vertically integrated provider of small launch services, satellites, and spacecraft components. Our mission is to open access to space to improve life on Earth. Our team is over 1,300 people strong and we're adding to it every week. Collaboration is at our core – every idea is heard, and everyone makes a difference. Teams are nimble, decisions are made quickly, and we are action oriented.

We are currently seeking a Quality Engineer II, Space Systems to join our highly dynamic team based out of Long Beach, CA. You will be responsible for managing and resolving quality issues and meeting strict delivery targets during development, production line commissioning, and continuous production. The Quality Engineer II will work collaboratively with internal stakeholders resolving and determining solutions to address root cause issues.

New Manufacturing Line – Space Systems

Candidate will provide guidance and support on quality requirements to Rocket Lab Space Systems division through design, prototype, and development of a product line production plan for Photon satellite systems, subsystems, and components.

What you'll get to do:

• Develop and implement new Quality Control Processes and Standards.
• Lead, facilitate, and participate in root cause investigations.
• Ensure adherence to QMS policy and procedures within their work center.
• Efficiently communicate status of evaluation and disposition to leadership.
• Lead and coordinate management of non-conforming hardware, including ticket dispositions, analysis, and improvement projects.
• Lead cost saving initiatives, especially related to product yield.
• Contribute to design reviews to reduce quality defects and time lost due to non-conformances.

You'll bring these qualifications:

• Bachelor's degree in Aerospace, Electrical, Industrial, Mechanical or Material Sciences Engineering.
• 4+ years of experience in a quality, manufacturing, or design engineering.
• GD&T knowledge
• Extensive knowledge or certification on IPC J – STD, IPC A-610
• Spacecraft experience
• Knowledge of quality tools such as; Lean principles, Six Sigma, Root Cause Analysis and Corrective Action, Advanced Product Quality Planning (APQP), Metrology, Process Failure Mode and Effects Analysis (PFMEA), Control Plans, AS9100
• Experience with managing projects and milestones

These qualifications would be nice to have:

• Experience successfully designing, developing, and introducing new product(s) to production.
• High level of hands-on quality and testing experience
• Proven track record of year-on-year product and process improvement activities
• Conducted both process and design failure modes and effects analysis (FMEA)
• Track record of leveraging new technologies to develop real shop floor solutions
• Experience supporting production of complex electro-mechanical, mechanical, or composites systems in high volume work centers and/or during production ramp-up

Important information:

FOR CANDIDATES SEEKING TO WORK IN US OFFICES ONLY:

To conform to U.S. Government space technology export regulations, applicant must be a U.S. citizen as defined by ITAR (22 CFR §120.15) or eligible to obtain the required authorizations from the U.S Department of State.

Rocket Lab provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment at Rocket Lab, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Senior Quality Engineer with medical device experience is required.

You will develop, maintain, and releasetop level procedures that comprise the Quality Management System (QMS). Conducts internal audits of the Quality Management System at the corporate, product group, and subsidiary levels.

All the support of these functions willinclude:
Assistance with external audits, oversight of the Operational Documentation System, and resolution of QMS/CAPA issues.

You will be the one topromotecontinuous improvement of the Quality Management System:

· This includes schedules, conducts and directs internal audits (QMS, product, or process) and follow-up audits of various product groups and subsidiaries. May conduct or assist with supplier audits as needed.

· Verifies the QMS meets requirements of ISO 9001, ISO 13485, 21 CFR 820, MDR and other regulatory/industry standards in support of allsubsidiary products and services.

· Generates and maintains the Corporate Quality Manual and Corporate Quality Procedures necessary to support compliance and certification to ISO/GMP/MDR and other related industry standards.

· Participates in second/third party audits from ISO registrars, FDA, customers, and others as required.

· Reviews, approves, and makes recommendations for the generation and continuous improvement of QMS non-product specific documentation supporting corporate, product group and subsidiaries.

· Works with all disciplines on Corrective and Preventive Action (CAPA) resolutions and may support product issues such as recalls, notices and field complaint investigations/reporting to authorities.

· Mentors quality engineers, inspectors, and other team members in all aspects of the QMS including audits, CAPA, procedure generation, and the corporate product development lifecycle process.

· Patriciates in and supports the periodic Management Review process.

Education & Experience:

· BS in Engineering or technical discipline with at least 8 years' experience in Quality Systems Engineering in the medical device manufacturing industry, or equivalent combination of education and experience.

· ASQ Certified Quality Auditor or equivalent with experience as a lead auditor preferred.

· Strong working knowledge of ISO 9001, ISO 13485, 21CFR Part 820, MDR and other requirements.

· Ability to generate and update procedures that support a modern best-in-class QMS.

· Excellent interpersonal, verbal, and written communication skills with a strong ability to multitask in support of cross-functional teams having various levels of QMS understanding.

· Highly detailed oriented with strong organization, leadership, project management, training, conflict resolution skills with demonstrated ability to self-manage and prioritize competing priorities.

· Expert level of experience with trouble-shooting and applying effective, systematic problem-solving methodologies to identify, prioritize, communicate and resolve complex quality issues.

· Risk management, reliability, verification, validation and design review experience preferred.

· Demonstrated proficiency with Word, Excel, PowerPoint, Access, Agile, Minitab and SAP including experience creating and working with databases, queries and reports.

· Six sigma training and certification is a huge plus.

Itis the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population.

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

The Jabil Healthcare facility in Clinton, Massachusetts is one of the most unique manufacturing office settings in the world. Encased in a brick carpet mill from the 1840s is 95,000 square feet of cleanroom manufacturing and expansive office spaces.

The manufacturing complex offers a wide range of capabilities to support all steps in our customers' product lifecycle, including product design, mold manufacturing, tooling, precision injection plastics molding, semi-automated and fully automated assembly, and final packaging. The site also provides product distribution and supply chain management for our customers.

Our Quality Systems Engineer, CSV Specialist is an entry level position that functions as an administrator for QMS and training software systems at the site. You will manage and maintain multiple QMS/LMS systems to comply with applicable regulatory and customer requirements. You will also establish and maintain CSV requirements for software systems used at the site.
IN YOUR ROLE YOU WILL
•Develop and maintain procedures/documents for software validation activities.
•Maintain master software application listing which identifies the software used by site.
•Lead periodic review process of user access list for software systems used at site.
•Coordinate with IT when hardware/software upgrades/updates are needed.
•Assist users with software validation activities.
•Develop to be a computer software validation SME for the site.
•Develop to be a data integrity SME for the site.
•Site Admin for QMS/LMS software systems.
•Approve/Review/Author documents such as User Requirement Specifications, Validation Plans, Risk Assessments, Test Protocols/Reports, Validation Summary reports.
•Ensure complaints use of Change Notices for documentation submission/changes.
•Participate in problem-solving and process improvement activities.
•Support all programs and initiatives related to the Jabil Healthcare Ethics code, Values and Sustainability programs.

MINIMUM REQUIREMENTS

Bachelor's degree preferred. 1-2 years of software validation experience, preferably in the medical device or pharmaceutical industry but any industry knowledge is acceptable. Knowledge of ISO 13485 and FDA part 820 is preferred. Excellent attention to detail, follow through and organizational skills. Must be self-motivated and able to work independently with minimal supervision/guidance. Preferred demonstrated working knowledge of CSV practices and requirements in a regulated medical device manufacturing environment (21 CFR Part 820,21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),etc.).


BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.


Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.