US MedTech Site Commercial Quality Lead
Depuy Synthes, a member of Johnson & Johnson Family of Companies, is recruiting for a US MedTech Site Commercial Quality Lead to be located in Bridgewater, MA.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
The Site Commercial Quality Lead is accountable for development, execution and oversight of quality and compliance programs designed to meet customer and business needs in compliance with regulatory requirements and the Quality Management System.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities :
- Responsible for quality & compliance oversight of the Returns operations at the site.
- Responsible for the management of all internal (ERC) and external Health Authority inspections (e.g. FDA, TUV/BSI) conducted at the site, including reviewing the preparation plan with on-site management.
- Ensure returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Company.
- Define and implement quality requirements and systems in alignment with department strategy.
- Support execution of the Quality System for the site.
- Ensure the Quality program maintains regulatory compliance.
- Support cross-functional teams to identify, investigate, document and correct quality issues related to the field returns process.
- Provide quality support for technology transfer and improvement of existing distribution processes including ensuring change control requirements are met.
- Support development of and review and approve standard operating procedures.
- Support registration maintenance for the site, as the need arises.
- Facilitate, coordinate and assist in Supplier Audits, when applicable.
- Make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure and metric reporting of CAPA, NC, and audit observations, as applicable.
- Establish and maintain relationships with NA DELIVER & Franchise customers in order to solve problems and meet changing competitive and regulatory environments.
- Coach and mentor Deliver business partners in the areas of root cause analysis, ISO and cGMP requirements as needed.
- A minimum of a Bachelor's degree is required. Focus degree in a Science, Engineering, Technology or Math is preferred.
Experience and Skills:
- A minimum of 4 years of relevant work experience in a regulated industry
- Knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485
- Ability to develop and administer a strategic audit plan that optimizes compliance and minimizes customer risk.
- Strong communication and collaboration skills to partner optimally across functions and operating units.
- Time and project management skills to handle multiple projects and deadlines.
- Strong problem solving and analytical experience.
- Innovative, quality, and global mindset.
- Experience within a diverse organization.
- Experience in health care industry
- Knowledge of Process Excellence Belt.
- Knowledge of ERP systems
- Excellent oral and written communication skills in English language.
- This position requires up to 25 % travel, domestic and/or international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.