Head of Quality

What You'll Do:

Leads the Quality team, accountable for the following areas:


• Serves as Quality System Management Representative, and as such: 1.) Ensures processes needed for the quality management system are established, implemented and maintained.  2.) Reports to top management on quality system performance and any need for improvement. 3.) Ensures the promotion of awareness of regulatory and customer requirements throughout the organization. 4.) Runs quality system Management Review meetings including input and output generation.
• Ensures integration of quality system requirements into product design and development activities throughout the product life cycle with particular focus on risk management, verification/validation, and manufacturing controls.
• Maintains quality systems pertaining to areas including but not limited to document control, quality audits, supplier evaluation, equipment calibration and maintenance, product inspection/testing, nonconforming part control, corrective/preventive action, and risk management.
• Evaluates, audits, approves, and monitors product and service suppliers. Coordinates supplier corrective actions as appropriate to ensure that quality requirements are met. Maintains supplier evaluation and approved vendor files.
• Manages quality system training process. Identifies personnel training requirements. Maintains training matrices and publishes status reports to ensure training requirements are met.
• Manages Corrective and Preventive Action (CAPA) process to ensure on-time completion of required activities. Verifies and validates action effectiveness by collecting and analyzing quality system data.
• Manages internal and external quality audits to ensure quality system compliance and effectiveness. Plans and coordinates audits, prepares audit responses, and coordinates corrective actions.
• Establishes quality inspection procedures and statistical sampling plans. Ensures that appropriate inspection and test equipment is obtained and properly used for inspections and tests.
• Leads nonconforming product review activities to efficiently disposition affected material. Investigates causes of nonconforming products and implements effective corrective actions.
• Maintains various lists, logs and tracking systems related to documents and records.
• Performs and documents product complaint investigations. Supports regulatory agency reporting as assigned.
• Analyzes product complaint and post market surveillance data and prepares summary reports.
• Ensures compliance with changing applicable state, federal, and international regulations and standards.

Required Skills & Experience:

• BS Engineering or life sciences required
• Minimum ten (10) years of medical product experience.
• Experience required in design, implementation and maintenance of quality management systems for medical product development, manufacturing, distribution, and post market surveillance.
• Proficiency required with international medical product regulations and standards.
• Proficiency required with application of statistical techniques for manufacturing and quality systems.
• Proficient with word processing, spreadsheet, presentation and document management software.
• Languages: Full professional proficiency in English is minimum requirement.

Bonus Points For:

• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential. 
• Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.
• Proven track record of organizing, hiring, and developing highly effective teams.