Senior Quality Engineer

Job Description

Job Description

The Senior Quality Engineer plays a critical role in ensuring that products and processes meet the highest standards of quality and reliability. This position is responsible for leading quality assurance initiatives, developing and implementing quality control systems, and driving continuous improvement across manufacturing and development teams. The Senior Quality Engineer collaborates closely with cross-functional teams including design, production, and supply chain to identify potential quality issues and implement effective corrective actions. This role requires a strategic thinker who can analyze complex data, lead root cause investigations, and influence quality culture throughout the organization. Ultimately, the Senior Quality Engineer ensures that customer expectations are consistently met or exceeded, contributing to the company’s reputation for excellence and compliance with industry standards and regulations.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Responsibilities:

• Program ownership of continued process verification (CPV)
• Lead and coach teams on complex investigations; ensure statistical/technical rigor and business continuity.
• Facilitate site PFMEA reviews; institutionalize risk registers; align mitigation control strategies.
• Quality by Design (QbD): Partner with Manufacturing, Science, and Technology (MSAT) for control strategy updates and CPV enhancements; enable Product Process Qualification (PPQ) readiness where applicable.
• Lead and manage continuous improvement projects focused on improving yield, Right First Time (RFT), and cycle time, from opportunity identification through implementation.
• Co-lead audit front-room topics; lead back-room coordination and commitments tracking.
• Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement.
• Train and mentor junior quality engineers and other team members on quality best practices and methodologies.

Minimum Qualifications:

• Bachelor’s degree in Biomedical Engineering, Quality Management, or a related technical field.
• 5+ years of experience in quality engineering or quality assurance roles within a manufacturing or product development environment.
• Strong knowledge of quality management systems (QMS) and industry standards such as ISO 9001, 21CFRPart 210 and 211.
• Proficiency in root cause analysis tools and methodologies such as 8D, Fishbone diagrams, and FMEA.
• Experience with statistical process control (SPC) and data analysis software.

Preferred Qualifications:

• Certification as ASQ CQE/CQA/CSSBB or equivalent.
• Experience working in regulated industries such as pharmaceuticals, medical devices, or aerospace.
• Familiarity with regulatory requirements including FDA 21CFR, ISO 13485, or AS9100 standards.
• Advanced degree in Engineering, Quality, or related discipline.
• Proficiency with quality management software and ERP systems.
• Experience leading or managing continuous improvement initiatives and/or cross-functional projects.
• Project management experience or relevant certification (e.g., PMP, Lean, Six Sigma).

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance 
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program 

  Timeline:  We will be accepting applications on an ongoing basis until position is filled.