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.
We're looking for a Shift QC Lead to support quality operations on the production floor. You'll lead non-conformance investigations, support lot disposition, and raise Quality Notifications. The role ensures corrective actions are completed and verified for assembly processes. You'll also provide QA support to the Shift Manager as needed.
This role is a shift role supporting our 4 Cycle Production schedule. This means 2 days ( 7am-7pm) and then 2 nights (7pm -7am).
Responsibilities:
- Managing the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment.
- Preparation of relevant work sheets and execution of In Process inspection tests
- Packaging Line clearance verification.
- Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process.
- Review In process controls, SOP’s, Test Methods and specifications to ensure Lab inspections are being carried out as per design intent.
- Analysis of data, quality metrics and trends of in-process inspection data.
- Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
- Preparation, review and approval of technical documentation.
- Perform training as required in the area.
- Ensure the smooth running of functions under your control.
- Any other reasonable duties which may be required by Quality management from time to time.
- Ensure testing equipment is functioning properly and call for repairs where equipment is faulty.
- Ability to Work in a cross functional team under the supervision of the Senior Quality Engineer.
- Identify areas for quality control improvement and implement new methods accordingly.
- Communicate quality or compliance concerns with urgency.
Educational Requirements:
- Qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance
Relevant Experience:
- 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 and Trackwise.
- 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.