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.
The aim of this role is to supports activities and procedures associated with Worldwide (WW) product complaints concerning embecta. In this role the Quality Engineer - Complaints Lab actively participates in the investigation of WW Customer complaints, quality experiments, analysis and reports to the Product Team. This associate will support projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements. This role will ensure that the investigations performed, and
reports prepared, are accurate, complete, and processed in a uniform and timely manner.
Responsibilities
- Application of technical principles, theories, concepts, techniques and quality sciences / tools. This includes FTIR and / or SEM analysis
- Develops solutions to routine problems of moderate scope, i.e. critical thinking
- Follows company procedures and makes basic procedural updates.
- Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements. Specifically: Ensure Customer complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
- Communicates across functions / departments for assigned areas of responsibility.
- Identify trends and quality issues raised during an investigation and escalate appropriately.
- Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
- Provide audit support (preparation, lab tour, related activities, etc.)
- Maintain good laboratory practices (GLP) consistent with regulatory requirements.
- Contributes to the completion of milestones associated with specific projects. Prepares reports, including quantitative / qualitative analysis, summaries and protocols. Revises policies/procedures.
Education And Experience
- BA/BSc in a Technical or Scientific Discipline
- 3+ years relevant experience in a similar role
- Good knowledge of regulatory requirements
- Knowledge of product failure modes
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
