Quality Engineer

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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.

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.

• 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 and 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.:كنولوج 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 rubbed investigations in determining the causes of those issues from a post‑market surveillance standpoint.
• Determines and implements solutions to monitor 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
  500 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.
• Works under consultative direction toward predetermined long‑range goals and objectives.
• Creates and supports documentation.

• B.S. 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 U.S. 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.
• Proficiency with Minitab.
• Some experience with Power
  
  BI.

• 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.

Competitive base salary based on experience and qualifications: $126,600 – $167,750 (subject to variation depending on physical location). Posted…