Quality Assurance Manager
Location: Indianapolis, IN
The Quality Assurance Manager is responsible for the daily execution and maintenance of the quality management system of a successful medical device manufacturer.
Duties and Responsibilities
- Manage the daily execution of the quality system, including timely management of investigations and corrective action processes.
- Analyze, evaluate, and coordinate information concerning factors affecting quality of products and implement preventive actions.
- Improve quality system procedures to streamline and prioritize processes while also ensuring they are effective and compliant with current regulatory requirements and standards.
- Oversee and control the quality inspection processes for production.
- Audit suppliers and control the supplier approval process, including the facilitation of corrective actions when necessary.
- Oversee the systems and workflows used for documentation control and record retention.
- Conduct initial employee training for the quality system processes.
- Review production processes and procedures for compliance to specifications and standards.
- Bachelor’s degree, preferably in engineering or technology (e.g., biomedical, manufacturing), or equivalent technical experience required.
- A minimum of 5 years of experience in regulated quality assurance required, preferably where FDA and CE Mark regulations applied.
- Background with quality system standards, preferably QSR and ISO 13485.
- 2 years, or more, in a supervisory role is preferred.
- Experience in ultrasound technology is a plus.
- Strong knowledge of manufacturing processes, required.
- Strong leadership and interpersonal communication skills, required.
- Self-motivated with a proactive attitude and the ability to work independently, required.
- Strong problem-solving and decision-making skills, required.
- Strong written and oral communication skills, required.
- Strong analytical and troubleshooting skills, required.
- Strong organizational and project management skills and experience, required.
- Proficiency in Microsoft Office, required.
About the company
Welcome to an established company, with a proven product, and a start-up feel. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.
Sonablate Corp. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.
Sonablate is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.