Senior Quality Engineer

Description

Primary Function 

The Senior Quality Engineer ensures products meet internal & external quality standards and regulatory requirements throughout their lifecycle, from design to manufacturing, by implementing and maintaining quality systems, conducting audits, and resolving issues. 

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, and system/services support. 

Principal Responsibilities

• Supports the establishment, maintenance, and improvement of the company’s Quality Management System (QMS) compliant with relevant regulations (ISO 9001, ISO 13485, FDA 21 CFR 820, etc.).
• Represents Quality be in core teams, cross-functional teams, providing compliance, development, manufacturing and post-marketed surveillance support.
• Leads or participates in internal and external audits and supports regulatory inspections.  Performs gap analysis and resolves gaps with effective resolution to achieve audit readiness. Identifies quality strategies, rationale, technical pathways during external audits. Plans and executes suppliers’ audits. 
• Provides direct quality engineering support to manufacturing; conducts quality assurance tests, analyzes quality data, identifies trends, and generates quality reports to track metrics and KPIs.
• Identifies and implements effective process control systems to support the development, qualification, and manufacture of products to meet or exceed internal and external requirements.
• Participates in design control & risk analysis/management activities (e.g., dFMEA, pFMEA), and ensures the accuracy and integrity of Design History Files (DHFs), Device Master Records (DMRs) and Device History Records (DMRs). 
• Verifies & validates manufacturing processes, equipment, and test methods to ensure they meet quality requirements and regulations and generates plans/protocols & reports (IQ, OQ, PQ) as needed.
• Investigates and resolves non-conformances, complaints, and other quality-related issues, and facilitates Material Review Board (MRB) reviews; leads/supports root cause investigations.
• Creates, reviews, and maintains quality documentation, including SOPs, CAPAs, test reports, and audit reports; initiates and/or approves change orders for documentation control per the QMS.
• Identifies training needs, performs & documents training, and verifies training effectiveness.
• Manages the company’s Calibration Program to ensure that Inspection, Measuring & Test Equipment (IMTE) are in calibration and relevant data/records are maintained; supports environmental monitoring processes.
• Drives process quality monitoring and improvement using statistical tools/methods such as control plans, Cpk, Cp, SPC, DOE, process data analysis, Gage R&R, and DMAIC. 
• Evaluates, qualifies and supports suppliers to ensure they meet quality requirements and regulations.
• Identifies areas for improvement in processes & products and implements changes to enhance quality, efficiency and reduce waste and costs.
• Represents Quality within cross-functional teams tasked with managing products through their lifecycle. 
• Performs miscellaneous duties and projects as assigned and required. 

Requirements

Training, Skills, Knowledge and/or Experience 

• 8+ years of related quality engineering experience required, including 3+ years of experience in the medical device or other regulated industry. Prior defense/aerospace industry experience & manufacturing engineering experience a plus.
• Demonstrated experience with quality engineering tools/methods, quality data collection & reporting, proficiency with Minitab or other statistical analysis software desired.
• Experience providing quality engineering support for complex electro-mechanical product manufacturing; exposure to opto-mechanical/electrical product manufacturing preferred.
• Detailed knowledge of FDA QSR, CGMP, ISO 13485, ISO 9001 and ISO 14971 standards/regulations.
• Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and supporting transfer of new products into manufacturing.
• Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge of Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems.
• Lean and/or Six Sigma Certification, ASQ CQE or similar certifications preferred.
• Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem-solving and root cause analysis, 5S and poka-yoke. 

Competencies:

• Project management and leadership skills, with proven experience leading cross-functional continuous improvement projects and teams to resolve quality issues in a timely and effective manner.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to organize and prioritize multiple tasks and meet deadlines, with attention to detail and accuracy.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong organizational, interpersonal and presentation skills. 

Education Requirements 

• Bachelor’s degree in engineering or other technical field or an equivalent combination of education and work experience. Master’s degree preferred.