Job Description
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 (http://twitter.com/embecta) .
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, the Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle 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 policies, while meeting all design control and other regulatory requirements.
This individual will be responsible for providing quality leadership, guidance and support in quality system methodologies for medical device development and manufacturing. This candidate will work directly with product development teams in support of the development and manufacturing of medical device products. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
In this position, the candidate will be responsible for:
- Leading all Quality related activities associated with building and maintaining external partnerships.
- Leading/supporting medical device design and development planning; quality planning and execution.
- Developing and maintaining risk management documentation.
- Supporting development of design verification and design validation documentation.
- Supporting test method development and validations.
- Ensuring embecta policies, procedures, practices and facilities are in compliance with all applicable corporate regulatory policies.
- Leading/supporting internal investigations, implementing corrective and preventive actions.
- Serving as a quality representative on one or more project teams engaged in product development or sustaining activities.
- Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971.
Experience and Education
- BS degree in engineering or technical sciences. MS preferred.
- A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
Additional Knowledge/Skills/Abilities
- Ability to engage with internal and external customers.
- Knowledge of design controls and 21CFR820, ISO 13485, and applicable medical device regulations, standards and guidance.
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.