Field Assurance (Quality) Manager Job in Tempe, Arizona US
Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
Identifies development needs and potentials of employees through formal development plans, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.
Interface with internal and external customers with regard to finished product quality issues and customer dissatisfaction.
Assure BPV’s complaint handling system complies with current US FDA/International regulations and standards (MDR/MDV/ISO) and the companies corporate standards and guidelines.
Ensures all reportable events are investigated accurately and in a timely manner – complying with Regulatory and BPV timelines.
Review and analyze complaint trending, failure modes and advise BPV Management when and as appropriate.
Assure distribution agreements and quality contracts meet complaint handling requirements in BPV’s best interests, with focus on timeliness of complaint investigations with OEMs.
Report trending on complaints to the appropriate product teams when and as appropriate.
Collaborate with design teams and Quality Engineering to investigate and evaluate appropriate product enhancements and assessing risk profiles for the new products.
Recommneds and keeps current with QE failure investigations and CAPAs to reduce redundant complaint investigations, and to encourage corrective actions for the reduction of complaints.
Assist in Regulatory, 3rd party and corporate audits.
Benchmark best practices within internal and externally for complaint management process.
Responsible for promoting a positive “teamwork’ environment within the department, and encourages leadership, responsibility and accountability for Field Assurance tasks, and metrics.
Perform other duties at the direction of the department head.