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 Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility. Ensure the systems and products comply with applicable government regulations. Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles. Essential functions include but are not limited to:
- Evaluate, design, implement and improve a production and process control strategy to achieve quality management and plant objectives.
- Participate on material review board. Provide quality engineering support to product/process validation effort.
- Review and approve changes to the device master record.
- Review and approve qualifications and validation protocols and results.
- Develop and approve strategic quality planning.
- Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e.: lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.
- Oversee the vendor qualification and certification programs in collaboration with supply management and supply quality engineer.
- Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Comply with all local, state, federal and embecta safety regulations, policies, and procedures.
- Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs.
- Build organization capability for quality engineering in the selection and mentoring of professionals.
- Build a strong interactive, working, and strategic relationship with embecta Holdrege manufacturing and Global quality management and other staff.
- Function as primary engineering respondent during FDA, ISO and other 3rd party audits and follow up on any action plans.
- Performs other duties as assigned by the manager and required to support the needs of the business
Basic Requirements: - Bachelor's degree in engineering, Quality Assurance, Mathematics/Statistical or Science related field required
- 3+ years in Medical Device Manufacturing, Validation, PFMEA
- 1+ years management experience
- Quality tools (MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, 5Y)
- Quality Systems
- strong knowledge of statistical and sampling plans
Preferred Requirements: - Master's degree desirable
- Project Management
- Six Sigma desirable
- Risk Management experience
- Strong applicable knowledge on Statistical and Sampling Plans
- Root Cause analysis principles
- CAPA
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.