Sr Quality Engineer - Planet Pharma

Top Needs:

1. design controls
2. process validation
3. Risk Management
4. Statistics
5. Test Method Validation

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.

Pay Rate: $50-60/Hr *Salary will be commensurate with candidate experience