Senior Quality Engineer

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 Client 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.

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.