Manager, R&D Quality Assurance

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Key Responsibilities

• Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process for complex electromechanical medical devices containing hardware, software, electrical and mechanical components.
• Responsible for Quality Engineering deliverables required within the product development process.
• Support Design Verification and Validation activities, including review of verification & validation protocols and reports.
• Assist in the analysis of product requirements and specifications.
• Participate in product design reviews and team meetings.
• Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report;
• Shelf-Life Studies strategy, including accelerated and real-time;
• Cleaning Validation.
• Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements.
• Ensure that technical information is accurate and in compliance with quality and regulatory requirements.
• Review Design Changes post design transfer.
• Work with third parties as needed to meet AbbVie requirements.
• Conduct DHF Audits throughout the development process. Develop Quality Plans. Maintain and Manage the DHF after product commercial release.
• Ensure that technical information is accurate and in compliance with international regulatory requirements.
• Maintain the overall site Risk Management process in accordance with ISO 14971 and other applicable standards.
• Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
• Provide quality support for the development of User Needs, Usability plans, reports and files.
• Ensures User Needs are mapped to appropriate Design Inputs.
• Implement Design Control/Risk Management process improvements to ensure a more effective, efficient, and compliant processes.
• Assist with global Quality Process harmonization and improvement efforts. Support/lead root cause investigations and implementation of corrective actions development.
• Prepare and analyze quality trend data, supporting the resolution of CAPAs to closure and verification of effectiveness.
• Participate in internal and external audits.

Onsite position/2 days a week WFH eligible.

Education & Experience

Must possess Bachelor’s degree in Science, Engineering, or a related field (or foreign equivalent) and eight (8) years of progressive, post baccalaureate experience as a quality engineer or closely related role within a medical device environment. Alternatively, Employer will accept alternate combination of a Master’s degree in Science, Engineering, or a related field (or foreign equivalent) and six (6) years of experience as a quality engineer or closely related role within a medical device environment.  With either combination of education and experience, position requires: Six (6) years of experience with medical device development life cycles and Design Control processes; Six (6) years of experience of 21 CFR Part 820, ISO 13485, and ISO 14971; Knowledge of IEC 62366, IEC 60601; Software development life cycles; writing Verification / Validation protocols and reports; MS Word, Excel, PowerPoint, and Outlook; drafting professional and technical communications to internal partners and regulatory bodies; applying concepts such as fractions, percentages, ratios, and proportions to practical situations; and applying sampling plans and statistical methods for data analysis.

Salary Range: $160,000.00 - $202,500.00 per year.

Apply online at https://careers.abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF41175P.

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We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.  This job is eligible to participate in our short-term and long-term incentive programs.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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