Shift QC Lead

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. 

Responsibilities:

·         Collaborate with the manufacturing core team to identify and prevent quality issues

·         Manage manufacturing non-conformances to ensure product quality and compliance

·         Verify packaging line clearance and ensure quality testing meets organizational standards

·         Maintain readiness for internal and external audits

·         Participate in Change Control processes

·         Review SOPs, test methods, and specifications for compliance

·         Analyze data, quality metrics, and trends to support continuous improvement

·         Prepare, review, and approve technical documentation

·         Train and mentor team members

·         Maintain high standards of safety and housekeeping

·         Communicate quality or compliance concerns with urgency

·         Complete product release when required

Educational Requirements and Relevant Experience:

·         Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance.

 Knowledge, Skills and Abilities:

·         2 – 3 years’ previous experience within similar role

·         Good knowledge and application ISO 9001/2000 or ISO 13485 environment coupled with a knowledge of FDA regulations and other standards.

·         Good experience in the preparation of Technical Documentation.

·         Good knowledge of Statistical Process Control and sampling techniques and standards

·         Good knowledge of SAP

·         Good experience in presenting and preparation of supporting documentation for site MRB meetings

·         A working knowledge of FDA/NSAI requirements for, and participation in, Regulatory audits. (Not mandatory)

·         Proven ability of working in a cross-functional team environment.

·         Excellent interpersonal and communication skills.

·         High level of computer literacy.

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.