Title:  Sr. Manager, Quality Engineering

Job Summary

This role will be onsite 4 days per week, with 2 days per week in Shlomi at sister site.

In this role, The Sr Manager, Quality Engineering & Compliance is responsible for leading the site’s Quality Engineering, Manufacturing Quality, and Quality Compliance functions. This role oversees engineering quality processes, design transfer, process validation, production quality oversight, customer complaints handling.

The position leads Quality Engineers for both design and operations and Quality compliance engineers and ensures that products, processes meet all applicable regulatory, customer, and corporate requirements. The Manager serves as a strong advocate for product and process quality across the full lifecycle — from design transfer and process validation through post-market surveillance.

This role works cross-functionally with Operations, Engineering, RA, Supply Chain, and external stakeholders, ensuring compliance with standards such as ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820, and applicable GMP requirements.

Essential Duties and Responsibilities

• Quality Engineering & Manufacturing Oversight: Lead review and approval of technical and engineering documentation including: DMR, DHF elements, IQ/OQ/PQ, Process validations and qualifications, Product specifications. Risk management files (dFMEA/pFMEA), Test methods, protocols, reports, Design transfer documentation
• Provide quality oversight for: New production line establishment Process validation activities Engineering changes (ECO/DCO), Software validations.
• Oversee production quality controls including: Raw material approval, Calibration approval (including deviations), DHR and batch record review, Labeling release, Nonconformance management (NCMR)  
• Drive Right First Time and Cost of Poor Quality (CoPQ) initiatives.
• Provide escalation support and structured problem-solving guidance.
• Customer Complaints & Post-Market Surveillance: Lead the site’s customer complaints handling process:
• Investigation and root cause analysis, Risk-based evaluation, Corrections and corrective actions, RMA/RGA management, Oversee complaints trending and reporting.
• Support RA in identification of Adverse Events and Hazardous Situations.
• Ensure feedback loop into risk management files and process improvements.
• Interface directly with customers regarding QA-related nonconformities and investigations.
• Leadership & People Management; Set priorities and objectives for Quality Engineering and Compliance teams. Supervise day-to-day performance, training, and development.
• Provide coaching on: Root cause analysis, Risk-based decision making, Regulatory interpretation, Technical problem solving, Ensure effective communication across functional and leadership levels.
• Promote a strong “Quality First” culture throughout the organization.

Education

• B.Sc. in Engineering, Science, Chemistry, Biology or related discipline (Relevant experience may be considered in lieu of degree)

Work Experience

• 8–10+ years of experience in Quality roles within Medical Device industry

• Proven experience in:

Design controls

Process validation

Risk management

Customer complaints handling

• Strong knowledge of: ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820
• 5+ years of people management experience, preferred experience of managing team leaders.
• Preferred Experience with: MasterControl, SAP, SharePoint, Statistical tools, Proficient in Microsoft Office Suite

Preferred Knowledge, Skills and Abilities

• Certified Quality Auditor – Advantage
• Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other international regulations.
• Familiarity with document management databases, particularly MasterControls and SAP.
• Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
• Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
• Excellent organizational skills with an ability to think proactively and prioritize work.
• Working knowledge of statistical data analysis.
• Thorough understanding of validation activities and risk management principles and techniques
• Strong problem-solving and critical thinking skills.
• Experience in medical industry or highly regulated industry.
• Previous leadership experience, preferably managing remote employees.
• Experience in regulated industry such as pharmaceutical and medical device.
• Project Management experience.
• Strong project management skills.
• Ability to manage competing demands, make timely and sound decisions, even under conditions of risk.

License and Certifications

• Lean Six Sigma Black Belt certification preferred
• CQA/CQE certification preferred
• Certified Quality Auditor preferred

Additional Requirements

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills.
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams.
• Read and interpret data, information, and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Demonstrates enthusiasm, takes accountability, and drives for results.