Director, Quality Assurance - Medical Manufacturing

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JOB OVERVIEW:

This position is responsible to develop, implement and direct the company’s quality assurance policies, procedures and methods to evaluate and improve the quality of complex products, materials, components and/or operations using standard procedures (e.g. 9001:2015, ISO 13485:2016, QMSR, etc.), and may take all reasonable and prudent steps necessary to maintain compliance with company and product registration requirements, with appropriate notification to, and/or direction from their direct supervisor.

KEY RESPONSIBILITIES:

• Direct all phases of highly technical quality assurance audit activities.
• Oversee the Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements as applicable.
• Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals
• Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.
• Oversee suppliers to assure the quality of their products, materials, components and/or operations.
• Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process.
• Stay current with new or potential business opportunities, and prepare for all QA activities.
• Direct and oversee the research for applicable FDA, ISO and ASTM/ANSI standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives, Medical Device Regulations, and FDA QS requirements).
• Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.
• Serve as the Management Representative for the site for interaction with regulatory agencies.
• Serve as Person Responsible for Regulatory Compliance (PRRC) at manufacturing locations for Corporate Brand products, under the European Medical Device Regulation.
• Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners.
• Assess the effectiveness of existing policies, guidelines and procedures and recommend changes.
• Consult and direct process and product transfer projects compliant to the applicable regulations, directives, and standards.
  
  Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed.
• Select, develop, and evaluate TSMs to ensure the efficient operation of the department.

SPECIFIC KNOWLEDGE &

SKILLS:

• Knowledge of ISO 9000 certification and maintenance.
• Knowledge of ISO 13485 certification and maintenance.
• Knowledge of the European Medical Device Regulation 2017/745.
• Knowledge of US FDA Quality Management System Regulation
• Knowledge of MDSAP country specific regulatory requirements

GENERAL SKILLS &

COMPETENCIES:

• Attract, retain, motivate, coach and develop team members for high performance.
• Excellent writing and communication skills.
• Excellent analysis and problem solving skills.
• Understand, interpret and act on financial information that contributes to business profitability.
• Ability to plan and manage complex projects, manage risks, costs, time and project teams.
• Excellent planning/ organizational skills and techniques.
• Communicate effectively with senior management and key stakeholders.
• Uses skills to lead teams to achieve company goals in effective ways.
• Ability to Influence, build relationships, navigate politics and manage conflicts.
• Broad and wide-range of professional and managerial skills…