Staff Quality Engineer

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.