Process Flow Leader-Empaque
CooperSurgical
Summary
Responsible for the Manufacturing/Packaging Area daily process flow operation focusing on the coordination of tasks, assigning priorities, verification and management of documentation associated to area. Assure process flow of product to comply with daily production plan. Ensure a good and healthy work environment through the compliance of procedures, company policies, operational and safety standards.
Job description
Responsibilities
- Generates NCR and applicable forms related to non-conforming product & materials.
- Assure Manufacturing/Packaging Area personnel perform their duties with high sense of Quality Awareness.
- Identify area disciplinary situations, provide feedback to the associate, and elevate situation to area manager or leader for consequent investigation.
- Assure all Packaging Area resources are available and within compliance, including certified human resources, operational equipment, calibration/PMs/Safety compliance, and available inventories, materials and operational supplies.
- Coordinate associates vacation plan.
- Assure released and packed product are sent to shipping area.
- Assure production goals are achieved and monitor area daily production performance.
- Perform safety daily monitoring audits and generate accidents/incidents reports as needed.
- Ensure correct resources are acting upon equipment repair situations and support within shift is granted.
- Assure Packaging Area information flow; prepare, coordinate and perform regular communications meetings.
- Promote a good work environment and monitor shift performance.
- Balance the workload among area personnel using line balancing concepts.
- Monitor and maintain ROLESS Program within job area.
- Perform and document periodical audits based on audit schedule.
- Promote 6S methodology within associates and suggest improvements.
- Provide audit findings, create actions and complete.
- Assist in investigations (data gathering of Quality and Process issues) and implement Corrective/Preventive Actions.
- Identify resources availability for Packaging Operation and coordinate special production meetings.
- Determine human resources requirements by roles.
- Execute Packaging operations as per applicable SOPs.
- Manage Safety & Emergency issues, implement safety corrective actions, and measure/improve safety shift indicators.
- Identify process equipment not performing as expected and communicate process capabilities and goals for Packaging operations.
- Generate work orders for equipment repair.
- Actively participate in Unit MRO including spare parts usage optimization, variance monitoring, and inventory reconciliation.
- Perform Lot Document Spot Screenings and identify corrective/preventive actions.
- Create safe conditions by design and provide continuous education of shift members in Safety.
- Ensure completeness of shift investigations of accidents.
- Identify possible causes of variation/failure/under performance for Packaging Operation and monitor mean time between failure for spare parts and breakdowns.
- Analyze through a structured approach to identify root causes.
- Define and prioritize Process KPIs for improvement, map process flow, and improve Process KPIs performance.
- Create innovative and permanent solutions using technology and methodology; develop and deploy implementation plans including validation.
- Identify opportunities for improvements in equipment performance and monitor unit performance indicators.
- Conduct people performance appraisals and feedback; coordinate overtime for non-exempt staff.
Quality System Responsibilities
- Complies with the Quality System Regulation (QSR).
- Executes job responsibilities as established in the Standard Operating Procedures (SOP).
- Follows the documentation procedures.
- Completes training for the qualification and certification, as required, to execute the job.
Environmental, Occupational Health and Safety Responsibilities
- Embraces, supports and aligns with corporate social responsibility policies while complying with applicable environmental, health and safety laws, regulations, procedures and corporate standards.
- Notifies conditions, near misses, accidents and incidents including environmental, that occurred in site's premises to prevent or eliminate any risk or exposure.
- Communicates any process changes that may impact Environmental, Health, Safety and Sustainability aspects to ensure compliance with regulatory obligations including protection of people and the environment.
- Promotes a safe and environmentally friendly workplace.
Requirements
- More than three years of experience in a similar position
- Bachelor's degree or more than three years of experience in a similar position
- Associate degree with three years of experience in a similar position
- Teamwork
- Good written and oral communication skills
- Responsible and highly driven – motivated
- Good decision making / judgment / information analysis
- Knowledge on effective meetings
- Basic knowledge in conflict management
- Basic knowledge of Microsoft Office Excel / Word / PowerPoint / BPCS / AGILE
- Basic concepts on problem solving, line balancing and root cause analysis
- Excellent interpersonal skills
- Highly motivated, self-starter, and responsible person
Company overview
CooperSurgical is a leading global medical device company specializing in women's health and fertility solutions. As a subsidiary of The Cooper Companies, the organization focuses on developing and manufacturing innovative products for reproductive medicine, fertility treatment, and women's healthcare. The company's comprehensive portfolio includes products for assisted reproductive technology (ART), embryo transfer systems, cryopreservation solutions, and diagnostic instruments used in fertility clinics worldwide. CooperSurgical plays a critical role in advancing reproductive medicine through its commitment to research, development, and clinical education. The company collaborates closely with fertility specialists and healthcare providers to address the complex needs of patients undergoing fertility treatments. With a strong presence in both domestic and international markets, CooperSurgical continues to expand its offerings through strategic acquisitions and organic growth, maintaining its position as a trusted partner in the fertility and women's health sectors.