Quality Assurance Leader

About this role:
Job Description
We are seeking a Quality Assurance Leader to assume overall responsibility for ensuring high-quality products and compliant quality management system processes to support clinical and commercial use of our products. This person will serve as Quality System Management Representative, including hosting regulatory authority audits.
Key Responsibilities:
Lead 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.
Required Skills and Qualifications:
Bachelor's degree in Engineering or Life Sciences
Minimum ten 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 a minimum requirement
Benefits:
This is an exciting opportunity to join a growing company where you can make a real difference. You will have the chance to work with a talented team of professionals who are passionate about delivering high-quality products and services. In return for your hard work and dedication, you can expect a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
Equal Employment Opportunity:
The company is committed to providing equal employment opportunities to all individuals, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law.