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Sr Quality Engineer

Northridge, CA 91325

Posted: 09/05/2024 Employment Type: Contract Job Category: Engineering Job Number: 610700 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
  1. design controls
  2. process validation
  3. Risk Management
  4. Statistics
  5. Test Method Validation

 

Years’ Experience Required: Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering.



A Day in the Life 
  • Participating in complex medical device product development per the FDA design controls starting from design planning through design transfer by demonstrating a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to product development.
  • Collaborate with cross-functional teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces.
  • Drive risk management deliverables by facilitating and generating design and process failure modes effects analysis (DFMEA/SWFMEA/PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process or design/software FMEAs.
  • Utilize the risk management and robust design principles to develop and identify essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development.
  • Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies.  Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record.
  • Collaborating with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc. to ensure work products comply with company procedures, acceptable qualitative and quantitative criteria, and global standards and regulations.
  • Collaborating with Ops in reviewing and approving Assembly Procedures, Travelers, and Work-Orders.
  • Generating master validation plans/reports and design transfer activities as applicable.
  • Partner with cross-functional teams in performing Process Qualification activities.
  • Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities (PPAP activities).
  • Effectively navigates & facilitates project teams with respect to internal processes and procedures ensuring the delivery of safe and effective products.
  • Driving clarity and consistency in documentation.
  • Review and Close out Non-Conformances (NCs) as they occur.
  • Leading CAPA projects and assisting post market analysis.
  • Participating in support of external and internal regulatory audits and inspections.
  • Driving Process improvement activities.
  • Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated.  Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
  • Performs other related duties as assigned.

Must Have
  • Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering.
  • design controls
  • process validation
  • Risk Management
  • Statistics
  • Test Method Validation

Nice To Have
  • Experience working in a regulated industry (e.g., FDA-regulated)
  • Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
  • Master’s Degree in Engineering, Quality, Regulatory, or related.
  • ASQ Certification in Quality or Reliability.
  • Strong understanding and hands on experience with the FDA production and process controls (P&PC), experience in planning of process validation / test method validation activities
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
  • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
  • Self-Starter with a sharp focus on quality and customer experience.
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About Northridge, CA

Ready to kickstart your career in Northridge, California? This bustling city in Los Angeles County is not just a hub for job opportunities but also offers a unique blend of urban and suburban living. Northridge boasts a vibrant arts scene with the Valley Performing Arts Center and The Soraya, inviting residents to enjoy world-class performances. With proximity to the stunning Santa Susana Mountains and the Pacific Ocean, outdoor enthusiasts can explore nature at Limekiln Canyon Park or take a leisurely stroll through the beautiful CSUN Botanic Garden. Indulge in the diverse and flavorful cuisine at local eateries while cheering on the CSUN Matadors or catching a game at the iconic Dodger Stadium nearby. Discover your next career move in Northridge and immerse yourself in a city that offers endless growth opportunities and an irresistible charm that's hard to resist. Explore our job listings now and take the first step towards a fulfilling career in this dynamic region.

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