Staff, Quality Engineer

embecta•Parsippany, NJ

6h•Hybrid

About The Position

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn , Facebook , Instagram and X . Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. As directed by the Director of Quality, the Post-Market Surveillance Staff Quality Engineer is accountable for supporting the continuing development, improvement, and implementation of post market surveillance process. This position actively participates in quality guidance and helps projects & quality teams for process improvements. This position also leverages post market data to drive corrective action, preventive action, and product enhancement, and oversees the generation of periodic reports required to fulfill regulatory requirements. The preference for this role is to sit hybrid in our Parsippany office 2 days a week, but we are also open to remote candidates. Applies consistent and extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results. Position specific responsibilities include support of the following, however, are not limited to: 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.

Requirements

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.

Nice To Haves

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.

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.