Production Supervisor

Responsible for day-to-day management of in-house Manufacturing of the Vero cassette. Conducts all manufacturing operations in accordance with quality policies, regulatory guidance and commercial demands for products and services.

Manages manufacturing technicians / operators in accordance with company and shop floor policies, including Regulatory and Safety requirements.

Leads initiatives to control and reduce manufacturing cost and will champion continuous improvement activities, including building a Lean culture.

Defines appropriate KPIs and develops visual dashboards that measure performance. Is responsible for building and sustaining a team that delivers against quality, financial and commercial expectations.

Responsibilities :

• Manage manufacturing area in accordance with QMS and GMP guidance and regulations for both device and pharmaceutical manufacturing.
• Establish and enforce shop floor controls ensuring the shop floor is safe and clean.
• Manage a build plan in support of service-level commitments.
• Manage and deliver daily production schedule (runs Start of Day / End of Day Meetings).
• Ensure each room is staffed properly (Headcount, Training, Leadership).
• Establish KPIs and monitor and report performance on a regular basis.
• Review log books and batch records daily to ensure completeness and timely reviews.
• Control inventory on the production floor; Manage compliance of material and labor with work orders and reconciles and variances.
• Investigate and report on any non-conformities including identifying and implementing appropriate corrective actions.
• Recruit, train and retain top manufacturing talent. Includes a regular commitment to networking and maintaining a bench of direct labor candidates.
• Create individual development plans and provide regular performance feedback.
• Scale manufacturing in support of commercial readiness objectives and sustain manufacturing throughput in support of commercial and financial goals.
• Provide resources to assist with pilot production and early stage design transfer activities.
• Champion cost-reduction initiatives that are impacted by labor controls.
• Demonstrate deployment of Lean tools for Visual Management, Problem Solving and Value Stream Optimization.

Minimum Qualifications :

• 10+ years Quality and / or Manufacturing experience with 5+ years of Supervisory experience in the U.S. Food and Drug Administration industry.
• Strong knowledge of FDA QSR, MDD and ISO 13485 : 2016 requirements.
• Thorough knowledge of GMP, CFR, and factors impacting compliance.
• LEAN Methodologies and Tools.
• Commitment to excellence and high standards.
• Detail-oriented, highly organized, reliable, and accurate in work.

Skills :

• Excellent verbal and written communication skills.
• Ability to manage priorities and workflows.
• Versatility, flexibility, and willingness to work within constantly changing priorities with enthusiasm.
• Demonstrated ability to plan and organize.

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