Senior Manager Manufacturing, Healthmark

Job Overview

Manages Healthmark clean testing manufacturing activities to meet organizational objectives for schedule achievement, cost management, quality, safety and efficiency for all manufacturing operations while ensuring compliance with safety, state and federal regulations

Job Responsibilities and Essential Duties

• Manages manufacturing operations meeting quality, productivity, scrap, cost effectiveness and housekeeping.
• Ensures all Device History Records (DHRs) are complete, accurate, and audit ready.
• Manages manufacturing operational standards by monitoring capacity, productivity, schedule achievement and quality performance, implementing corrective actions.
• Manages manufacturing financial standards by monitoring costs; implementing corrective actions.
• Continuously improves by assessing manufacturing and business processes for efficiency improvement, benchmarked against best industry practices.
• Collaborates with Sustaining Engineering, R&D, Quality and staff members to analyze and resolve major process and quality issues, in conjunction with the CAPA and nonconforming materials processes.
• Write manufacturing work instructions alongside sustaining engineering and quality to help ensure products are designed for manufacturability
• Provides leadership in selecting, developing and evaluating personnel to ensure the efficient operation of the manufacturing floor, while fostering a "quality-first" culture that understands the regulatory consequences of non-compliance
• Manages departmental staffing needs and adjusts accordingly to ensure optimized flexible trained workforce.
• Directly supervises manufacturing supervisors and/or team leaders/group leaders.
• Drives compliance with all regulatory requirements related to facility registrations, product registrations, quality system compliance, and personnel safety.
• Represents Medical Device Manufacturing during FDA inspections, ISO 13485/ISO 9001 external audits as well as all internal and corporate audits as needed.
• Provide necessary information to FDA that demonstrates compliance with cGMP's.
• Maintains safe and healthy work environment by following and enforcing standards and procedures; complying with legal regulations.
• Participates in Monthly Quality Review Board and Management Review as requested and supplies KPI data as needed to support corporate objectives.
• Supports manufacturing training coordination and HR initiatives.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

Minimum Requirements

• Bachelor's degree (Operations Management, Engineering or other technical discipline preferred).
• A minimum of seven years Operation Management and/or Manufacturing Experience (or equivalent) in a regulated medical device environment, specifically within FDSA-regulated Class II medical devices, including ownership of validated processes and design transfer activities.
• Strong computer skills, including MS Office (Word/Excel) applications.

Required Knowledge, Skills and Abilities

• Experience in implementation and sustainability of Lean Manufacturing concepts. Six Sigma blackbelt or advanced lean implementation a plus.
• Experience in cGMP implementation and elements, notably DMR/DHR authorship, equipment qualification and process validation
• Proven leadership skills creating an engaged associate environment.
• Ability to manage multiple priorities in a manufacturing plant setting.
• Flexible and adaptable to changing circumstances, procedures, and environment.
• Expert level working knowledge of Quality Systems Regulation (QSR) requirements for medical devices (ISO 13485, 21 CFR 820) with hands on experience.
• Solid technical background and understanding of engineering and quality principles and procedures, e.g. DoE, root cause analysis, data analysis techniques, etc.
• Demonstrated business ethics, integrity and discretion required.
• Knowledge of SAP a plus.

Supervision/Management Of Others:

• Responsible for the development and management of non-exempt and/or exempt personnel. Supervisory Skills - Ability to coach, develop and motivate associates to optimize team effectiveness and enhance team interactions. Ability to impact team morale, sense of belonging and participation while reinforcing individual accountability for regulatory compliance and product quality.

Internal and External Contacts/Relationships

• Main contacts, internal;
  
  
  
  • Manufacturing Managers
  • Manufacturing staff and operators
  • Warehouse Management
  • Production Planning
  • Sustaining Engineering / R&D
  • Quality/Regulatory
  
  
  
  

Environmental/Safety/Physical Work Conditions

• May work extended hours to support manufacturing shifts.
• Duties are performed in a controlled environment and office setting.

Salary range: $150,000-$180,000

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