MAIN JOB RESPONSIBILITIES / COMPETENCIES

1. Manage and coordinate the activities associated with various manufacturing processes in a cGMP-compliant manufacturing operation, including, but not limited to, assembly, sterilization, packaging, Clean Room operations, machining and material processing.

2. Manage and coordinate shelf life, qualification, and validation production runs between

3. Responsible and accountable for production schedule adherence, productivity and product quality

4. Ensure that Manufacturing personnel have been trained in required SOPs, in accordance with the established Training SOP.

5. Accountable for departmental compliance with production procedures, manufacturing specifications and regulatory requirements.

6. Review production operations and make recommendations for cost reduction and quality/productivity improvements.

7. Ensure that production activities are documented and records are maintained in accordance with applicable SOPs.

8. Maximize department, equipment and manpower utilization.

9. Ensure adherence to Company safety policies and procedures.

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

11. Provide the leadership necessary to maximize the productivity of each employee, including active listening, ongoing feedback, meaningful development and growth opportunities as well as an effective documented review process.

12. Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING

• A Bachelor’s degree, science or engineering preferred or equivalent combination of education/experience.

• Graduate business degree a plus

EXPERIENCE

• 3 years manufacturing experience in medical device, pharmaceutical or other FDA-regulated industry

• Leadership experience

• Clean room operations experience a strong plus

SKILLS

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

• Excellent team building and interpersonal skills

• Excellent prioritization, multi-tasking and organization skills

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.

STAAR Surgical

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