Director of Quality Assurance - Manufacturing

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.
• Select, develop, and evaluate TSMs to ensure the efficient operation of the department.

GENERAL SKILLS & COMPETENCIES

• Outstanding management and leadership skills and ability to attract, retain, motivate, develop, mentor and coach team members for high performance
• Outstanding verbal and written communication skills and ability to resolve disputes effectively
• Outstanding presentation and public speaking skills
• Expert independent decision making, analysis and problem solving skills
• Understand, interpret and act on financial information and external trends that contributes to business profitability
• Plan and manage complex and successful projects; understand available resources, develop timeline, budget and assign areas of responsibility
• Lead teams to achieve company goals and solve complex business issues in creative and effective ways
• Expert planning and organizational skills and techniques
• Communicate effectively with senior management and key stakeholders
• Excellent negotiating skills and ability to effectively manage internal and external relationships
• Influence, build relationships, understand organizational complexities, manage conflict and navigate politics
• Broad professional and managerial skills with a full understanding of industry practices and company policies and procedures
• Lead and develop virtual teams
• Expert in multiple technical and business skills
• Strategic planning skills

MINIMUM WORK EXPERIENCE

• Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 5 or more years of management experience.
• Experience managing the quality management systems of multiple manufacturing locations is preferred.

PREFERRED EDUCATION

• Bachelor's Degree or global equivalent in Engineering, Science or related technical discipline.
• Master's degree preferred.
• RAPS and ASQ or other equivalent Certifications preferred.

COMPENSATION

• The posted range for this position is $144,235 to $198,323 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role.
• Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

OTHER BENEFITS

• Medical, Dental and Vision Coverage
• 401K Plan with Company Match
• PTO
• Paid Parental Leave
• Income Protection
• Work Life Assistance Program
• Flexible Spending Accounts
• Education Benefits
• Worldwide Scholarship Program
• Volunteer Opportunities