Lead Product Quality Engineer

Hologic; Town of Newark (WI); Presencial; USD 119.000 - 187.000; Jornada completa

Descripción de la vacante

Hologic is seeking an experienced quality engineering leader to act as the product expert for assigned lines and drive compliance with FDA quality systems, ISO 13485, and related standards. You will mentor engineers in root cause investigations, risk assessments, CAPAs, and validation activities while coordinating cross-functional investigations and changes.

The role requires deep knowledge of Design Control, risk management, and problem-solving across complex complaints, with ongoing

Formación

• Bachelor's degree required in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• 8+ years’ experience in an FDA-regulated industry; 6+ years with a master's; 3+ years with a PhD.
• Demonstrated experience leading root cause analysis and complex complaint investigations; experience in product development/R&D is beneficial.

Responsabilidades

• Serve as the product expert for assigned product lines and develop deep knowledge of product design, functionality, clinical use, and risk management documentation.
• Serve as process owner for Product Quality Engineering processes, ensuring compliance and effectiveness; provide training to engineers.
• Coach/mirror engineers on complaint investigations, risk management, test method validation, and documentation.

Conocimientos

FDA Quality System Regulation

Design Control

Root Cause Analysis

CAPA

Risk Management

GMP

GDP

Project Leadership

Mentoring

Communication

Educación

Bachelor’s Degree in Engineering

Descripción del empleo

Essential Duties and Responsibilities

• Serve as the product expert for assigned product lines, developing in-depth knowledge of product design, functionality, clinical use, known failure modes, and product risk management documentation as applicable.
• Serve as process owner and subject matter expert for Product Quality Engineering processes and associated procedures, ensuring they remain compliant, effective, and consistently applied across teams. Provide training and mentorship to Product Quality Engineers on processes and procedures as needed.
• Coach/mentor Product Quality Engineers, providing technical guidance on complaint investigations, root cause analysis, Risk Management, risk assessment (including Health Risk Assessments and Health Hazard Evaluations), test method validation and documentation. Additionally, review documentation for technical quality and compliance.
• Lead and provide coaching on the prioritization, evaluation and documentation of complaints and investigations based on product risk to ensure timely completion of investigations.
• Drive consistency and best practices across the Product Quality Engineering team, including implementation of any improvement opportunities (new tools, technologies, and methods).
• Lead investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders.
• Partner with cross functional team and communicate root cause, determine if CAPA is required, recommended changes and scope effort to implement changes as needed.
• Responsible for executing the Health Risk Assessment and Health Hazard Evaluation, and coordinating with internal teams when needed, for evaluation of on market product, leading an efficient and effective analysis of situation, including problem definition and impact.
• Perform data analysis and trending of data related to complaints and identified failure modes, identifying mitigations for any threshold risks and owning preparation and presentation of data and findings to internal stakeholders where applicable.
• Lead cross functional team to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation, as applicable.
• Develop or improve testing methods used during complaint investigation and root cause activities.
• Train and mentor the complaint intake team to build technical product knowledge and improve complaint evaluation quality, providing expertise on complex investigations as needed.
• Assess changes of products for impact to design and risk management, determine supporting information required for implementation of changes.
• Provide Post-Market feedback, identified through complaint trending and other forums, to Operations, Engineering and R&D to improve design and manufacture of devices in the field and in development.
• Lead investigations in the field at customer sites partnering with field-based teams, including sales and service.Urgently identify and provide timely resolution of field quality issues while upholding the Hologic brand image and values.
• Present product quality metrics to Leadership, explain root cause, and recommend actions/resolutions.
• Active participation in internal and external audits, serving as product subject matter expert (SME), including but not limited to facility and supplier audits and Notified Body and FDA inspections.
• Review team inputs for monthly Quality Investigation Review boards, preparing and presenting material where applicable.

Supervisory Responsibilities

Carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications

Education

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)

Experience

• Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 8+ years’ experience, 6+ years with master’s degree, 3+ Years with PhD.
• Experience in an FDA regulated industry
• Demonstrated experience leading root cause analysis and complex complaint investigations; experience in product development/R&D is beneficial
• Demonstrated experience coaching, mentoring, or training engineers or technical staff

Skills

• In-depth knowledge of FDA Quality Management System Regulation (21 CFR 820), especially Design Control requirements, ISO 13485, EU Medical Device Regulation (EU MDR 2017/745), ISO 14971 Risk Management, GMP, and GDP
• Proven ability to lead project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
• Strong knowledge of root cause analysis tools and ability to lead, and coach others in, root cause activities for complaint investigations, NCs, CAPAs, etc.
• Excellent communication and presentation skills, including the ability to influence cross-functional partners
• Strong coaching and mentoring skills, with the ability to develop technical capability in others
• Ability to develop and maintain product knowledge; serving as the subject matter expert for assigned product lines
• Ability to manage multiple projects and priorities at one time
• Works with high degree of autonomy and independence, requiring minimal oversight on highly complex problems with analysis requiring a variety of factors.

Preferred:

• Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
• Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for a regulated product
• Familiarity with requirements analysis, including development of testable and measurable specifications
• Knowledge of risk based and statistical analysis concepts
• ASQ Certified Quality Engineer (CQE) or equivalent

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $119,300 - $186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.