Why you should apply for a job to Johnson & Johnson:
Ranked as one of the Best Companies for Women in 2020
4.2/5 in overall job satisfaction
4.3/5 in supportive management
72% say women are treated fairly and equally to men
88% would recommend this company to other women
85% say the CEO supports gender diversity
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
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Position summary
DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineering (QE) Manager, Product Software Development to be located in Boston, Massachusetts .
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The Quality Engineering Manager, Product Software Development will be accountable for medical device software quality for VELYS Digital Surgery products. This individual will also provide strategic leadership for product software quality engineering initiatives within DePuy Synthes and as a representative within the Medical Technology sector of Johnson and Johnson.
The Quality Engineering Manager, Product Software Development, will be responsible for implementing and maintaining the Medical Device Software QMS and will provide quality oversight for the development and maintenance of medical device software/systems. They will provide leadership and talent management to direct reports.
Key Responsibilities:
- Support the design, development, testing and maintenance of Medical Device Software, including Software as a Medical Device (SaMD) products
- Provide leadership, guidance and expertise on the software development process, procedures, and practices. Improve processes to reflect state of the art practices and drive continuous improvement
- Manage Direct Report(s) and supervise their projects to ensure compliance to local procedures and regulatory requirements.
- Support regulatory filings and registrations
- Support internal and external audits or inspections of Medical Device Software products and processes and own Non-conformances or CAPAs and drive root cause investigations
- Provide expertise in applicable industry standards and regulations including, but not limited to IEC 62304, FDA QSR and Guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, and IEC 62366-1
- Provide technical support for audits of software suppliers and consultants
- Know, understand, incorporate, and follow all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
What are Johnson & Johnson perks and benefits
Child care benefits
Paid maternity
Unpaid maternity
Paid paternity
Unpaid paternity
Paid adoptive
Short term disability
About the company
Why you should apply for a job to Johnson & Johnson:
Ranked as one of the Best Companies for Women in 2020
4.2/5 in overall job satisfaction
4.3/5 in supportive management
72% say women are treated fairly and equally to men
88% would recommend this company to other women
85% say the CEO supports gender diversity
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
