Senior Manager, RDQA

ABBVIE; Branchburg Township (NJ); On-site; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Manager, R&D Device Quality to lead quality activities for medical devices within combination products. You will guide design control, risk management and usability initiatives across development teams to ensure compliant, safe products.

You will collaborate with engineering, manufacturing and regulatory affairs to drive risk assessments, CAPA, and design verification/validation, while supporting audits and continuous improvement across the site.

Qualifications

• 10+ years’ experience in Medical Device industry with 2+ years in project management.
• BS in Engineering or Scientific discipline; MS preferred.
• Strong knowledge of Medical Device development activities.
• Proven expertise with interpreting and leading others in compliance with 21 CFR Part 820, ISO 13485, ICH Q9, 21 CFR 4, Canadian Medical Device Regulation, ISO 14971, MDD, EN 62366 and ANSI HE75.
• Skilled in requirements analysis with testable and measurable specifications.
• Familiar with reliability analysis and test methods.
• Good verbal and written communication, especially technical reporting.
• Ability to influence internally and with external partners.
• Experience interacting with regulatory agencies and notified bodies.
• Knowledge of CAPA, SPC, quality risk management, FMEA, DOE and other quality tools.

Responsibilities

• Provides quality system methodology guidance across design, development and change control.
• Participates in cross-functional teams evaluating design docs for quality, risk and manufacturability.
• Translates design requirements into manufacturing specs to achieve design for manufacturability.
• Acts as technical resource for investigations to drive root-cause analysis and corrective actions.
• Leads DRM-related activities: robust engineering, reliability predictions, CTQ’s and VOC.
• Ensures projects comply with FDA QSR, ISO 13485, ICH Q9 and other standards.
• Oversees clinical batch manufacturing QA, including qualification and batch release.
• Develops site QA strategies and improves design control and risk management; supports MDCP QMS and CAPA.
• Supports regulatory audits as SME; drives harmonization and data-driven improvements.
• Keeps current on global quality trends for pharma and medical devices.
• Supports updates to quality standards for conformance and continuous improvement.

Skills

Medical Device development

Quality systems

Risk management

FMEA

DOE

CAPA

Root cause analysis

Project management

Regulatory influence

Verbal/written communication

Education

BS in Engineering or Scientific discipline

MS preferred

Tools

CAPA systems

FMEA

DOE

SPC

Job description

• Compensation: USD 124,500 - USD 236,500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The Senior Manager, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing directions on applicable design control, human factors/usability engineering, and risk management processes. This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control system is effectively established, executed, and maintained. This position will participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, and development of the risk management plans.

Responsibilities:

• Provides quality system methodology guidance, support and review for medical device products throughout the design and development and change control processes.
• Actively participates in cross-functional design teams assessing design documentation for quality characteristics, including product requirements, safety risk management, design verification, design validation, manufacturability, serviceability, biocompatibility, sterilization, packaging and reliability.
• Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
• Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development.
• Facilitates and leads design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices. This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
• Provide quality oversight for clinical batch manufacturing, including equipment qualification, adherence to approved processes, data traceability, and clinical batch release.
• Develop and implement site QA strategies, improve design control and risk management processes, support a consistent and compliant MDCP quality management system, oversee Operations QA activities, and contribute to CAPA investigations and resolution.
• Support regulatory audits and inspections as subject matter expert, while driving quality harmonization, data-informed improvements, and initiatives that enhance process effectiveness and product performance.
• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Devices worldwide.
• Supports changes to quality standards to ensure conformance and continuous improvement.

Qualifications

• 10+ years’ experience working in the Medical Device industry, 2+ years in project management
• Minimum of a BS in Engineering or Scientific discipline; MS preferred
• Strong knowledge of Medical Device development activities
• Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management, 21 CFR 4 Regulation of Combination Products, SOR 98-282 Canadian Medical Device Regulation, ISO 14971 Risk Management Standard, MDD, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
• Skilled in requirements analysis, including testable and measurable specifications
• Familiar with reliability analysis and test methods and test method validation
• Good verbal (including presentation) and written communication skills, especially technical report writing
• Ability to effectively influence others and work within the Allergan organization as well as partnering with external partners
• Experience interacting with regulatory agencies and notified bodies
• Good knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.