Be an early applicantLess than 25 applicants
Johnson & Johnson · 3 days ago
Quality Engineer II, Post Market Surveillance
Danvers, MA
Full-time
Onsite
Mid Level
$76K/yr - $122K/yr
4+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesHealth CareMedical Device
Insider Connection @Johnson & Johnson
Responsibilities
Domain expert accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and communicating PMS data in any required forums.
Creates and presents post market surveillance data for management review.
Participates in multi-functional and global teams to implement post market surveillance activities.
Collaborates with multi-functional partners to investigate relationships between key risk factors, medication, and procedural information and adverse events/complaint rates.
Collaborates with multi-functional partners to build factual annual reports and other post market surveillance activities when such activities are required as part of the post market surveillance commitments.
Stays on top of current trends in literature and research pertaining to data analysis for complaints / adverse event data.
Ensures compliance with QSR, MDV, MDR, MPR, and any applicable country regulations and requirements regarding post market surveillance trending.
Support additional information requests from global regulatory agencies.
Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations.
Strong analytical skills including trend and statistical analysis, interpersonal, and leadership skills.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
A minimum of Bachelor’s degree is required
A minimum of 4 years’ experience in medical devices specifically related to post market surveillance
Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability
Must have excellent written and verbal communication skills and have a strong solid understanding of the development, application, and measurement of quality performance metrics
Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations
Strong analytical skills including trend and statistical analysis, interpersonal, and leadership skills
Preferred
Experience with fulfilling requests from internal and external audits is helpful
Statistical knowledge and understanding
Proven successful project management
Solid understanding and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR
Demonstrated ability to create accurate and factual post market surveillance documentation consistent with applicable quality standards
Ability to travel 10% domestically and internationally
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short- and Long-Term Disability Insurance
Business Accident Insurance
Group Legal Insurance
401(k) Retirement Plan
Pension Plan
Long-Term Incentive Program
Vacation
Sick Time
Holiday Pay
Work, Personal, and Family Time Off
Company
Johnson & Johnson
Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.
10,001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (43)
2022 (55)
2021 (40)
2020 (30)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO· nyse:JNJ
Leadership Team
Alex Gorsky
Chairman & CEO
Dominic J. Caruso
Vice President, Finance and Chief Financial Officer
Recent News
Startupticker-Ch
2024-05-29
2024-05-26
bloomberglaw.com
2024-05-24
Company data provided by crunchbase
