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embecta · 1 week ago

Staff, Quality Engineer

USA NJ - Parsippany

Full-time

Hybrid

Lead/Staff

$127K/yr - $168K/yr

8+ years exp

embecta is a global diabetes care company that empowers people with diabetes to live their best life through innovative solutions. The Post-Market Surveillance Staff Quality Engineer is responsible for supporting the development and implementation of post market surveillance processes, driving corrective actions, and overseeing regulatory reporting requirements.

DiabetesHealth CareMedical

H1B Sponsor Likely

Responsibilities

Leads special investigations, in conjunction with other functional departments, to assess and determine suitability of product, impacts to regulatory compliance, and patient safety for products outside of embecta’s control

Provides support to Post-Market Quality (Regulatory) partners in execution of applicable field action activities

Proficiently executes concise and effective communication of investigational findings to relevant stakeholders within the organization

Creates/manages product Plans/PSURs in collaboration with Medical/Regulatory Affairs, R&D, Customer Service, and others

Leads projects to improve the sensitivity and specificity of surveillance processes

Coordinates presentation of monthly reviews of the post market quality data and documents meetings (i.e.: meeting minutes and action items)

Collaborates and interacts with internal teams including Manufacturing, R&D, Product Quality, Customer Quality and Supplier Quality

Follows procedures to investigate and analyze complaint trending and field data to determine significant issues for investigations in determining the causes of those issues from a post market surveillance standpoint

Determines and implements solutions to monitoring customer and product quality issues through data analysis

Assists with verification and validation activities of post market surveillance reports

Extracts monthly post market quality data and maintains compliant records

Monitors changes in post market quality signals and documents appropriately

Creates presentations summarizing major product quality issues and complaint trends

Develops advanced technological ideas and guides their development into a final product, process or business opportunity

Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations

Implements and communicates the strategic and technical direction for the product/project team

Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context

Creates and supports documentation

Qualification

Engineering DegreeMedical Device ExperienceFDA RegulationsISO StandardsMicrosoft OfficeMinitabPowerBICertified Quality EngineerCertified Quality AuditorAnalytical ThinkingProblem SolvingTeam Collaboration

Required

BS Degree in Engineering or related field

8+ years of experience in the medical device industry with knowledge in the area of customer relations, PMS, complaint trending, MDR submissions, FDA regulations, GMP and clinical laboratory functions

Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, ISO 14971, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements

Full proficiency in Microsoft Office required

Proficiency with Minitab

Some Experience with PowerBI

Preferred

Certified Quality Engineer and Certified Quality Auditor (preferred)

Self-motivated and directed, requiring minimal supervision

Demonstrated ability to work in teams to obtain results

Effective skills in analytical thinking and problem solving

Benefits

Medical

Dental

Vision

Retirement savings plans

Paid time off

Annual bonus

Company

embecta

Embecta is a provider of diabetes healthcare services.

Founded in 2022

Franklin Lakes, New Jersey, USA

1001-5000 employees

https://www.embecta.com

H1B Sponsorship

embecta 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

Represents job field similar to this job

Trends of Total Sponsorships

2022 (2)