This job is responsible for the 4th shift (weekend Fri/Sat/Sun nights)

JOB OVERVIEW

1. Manage and coordinate the activities associated with processes used in operations.

2. Responsible and accountable for schedule performance, productivity and quality.

3. Responsible for new hires. Ensure personnel have been trained in required SOPs/WIs and adequate cross training and coverage for all areas of the business.

4. Accountable for compliance with procedures, specifications, and regulatory requirements.

5. Review operations, and make recommendations for cost reduction and quality/productivity improvements.

6. Ensure that department activities are documented and records are maintained in accordance with applicable SOPs.

7. Maximize department, equipment, and manpower utilization.

8. Ensure adherence to Company safety policies and procedures.

9. Provide employee development opportunities through coaching, delegating and cross-training.

10. Participate in verbal and written counselling/coaching and write employee evaluations (with support and final approval from management).

11. Conduct departmental meetings to ensure employees are informed of any procedural or policy changes.

12. Fill out report on quality events and assist management/engineering with investigating the cause of non-conformities within the area including impact on processes and products.

13. Assist with the onboarding process of new equipment.

14. Provide Lean Manufacturing training and support a lean initiative to staff.

15. Conduct periodic audits of manufacturing areas and report results accordingly.

16. Maintain a clean and safe working environment.

17. Monitor and prioritize workflow of manufacturing to meet demand.

18. Provide direction and schedules to the manufacturing department i.e. work on overtime scheduling for all teams.

19. Flexible to work as needed to support a 3 shift operation

20. Able to sit, walk, move around for long hours at a time.

21. Other duties as assigned.

EDUCATION & TRAINING

1. High School Diploma or equivalent required. Bachelor degree preferred, or equivalent combination of education/experience.

2. Previous supervisor experience preferred.

EXPERIENCE

1. Supervisory experience in a Clean room environment & medical device, pharmaceutical or other FDA-regulated industry preferred.

2. Developed proposals for process/productivity improvements.

3. Lean Manufacturing/ 5S experience preferred.

SKILLS

1. Ability to provide leadership and support in a changing and dynamic environment

2. Excellent verbal and written communication skills.

3. Excellent team building and interpersonal skills

4. Exceptional negotiation and conflict resolution attributes.

5. Excellent prioritization and organization skills with measurable and timely results

6. Demonstrated understanding of, and ability to practically implement, cGMP/QSR/ISO requirements

7. Efficient with computers including use of Microsoft Office Suite

8. Ability to continuously improve the performance of the group

9. Effective in determining the cause and solution to problems

10. Ability to work with cross functional teams to accomplish objectives

11. Strategic planning skills preferred.