Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Quality Manager II -Post Market Surveillance-31454
Description
The Manager II, Corporate Post-market Surveillance will report directly to the Director, Corporate Post-market Surveillance and provide leadership, corporate oversight, and subject matter expertise for BSC complaint handling and world-wide regulatory reporting policies, procedures, and associated electronic systems.
This includes but is not limited to setting and executing the vision, goals, metrics, and work standards for the management team to work cohesively and effectively. The role also includes development and maintenance of BSC corporate policies, procedures, and systems for complaint handling and regulatory reporting and managing and developing the corporate post-market surveillance work-team.
Key Responsibilities
Provide stewardship and oversight for BSC complaint handling and world-wide regulatory reporting policies, procedures, and associated electronic systems.
Provide complaint handling system and regulatory reporting subject matter expertise for the BSC Corporate Post-market Surveillance department.
Work closely with Corporate Quality Systems Management, other BSC Quality System owners, Site Complaint Management Centers , Complaint Investigation Centers , Information Technology, and Regulatory to ensure BSC complaint handling and regulatory reporting compliance and business value.
Interpret and execute complaint handling and regulatory reporting policies and procedures that typically affect BSC business units. Recommends and executes modifications to operating policies.
Develop and report on relevant BSC corporate complaint handling system metrics. Create trend reports, monitor, analyze, document, and report on potential areas of concern for business units, specific product lines (or families).
Manage the post-market surveillance work-team, set development plans, conduct performance appraisals periodically and fulfill other supervisory/management-related responsibilities for the department and organization as required.
Maintain and monitor complaint handling systems and metrics to ensure that all product complaint investigations received are appropriately investigated and reported per the company's complaint handling procedures.
The manager must possess the ability to work closely with legal staff, regulatory, medical and global safety teams, marketing, manufacturing, and sales management to provide effective stewardship for complaint handling and regulatory reporting.
Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.
Qualifications
Undergraduate degree is required. Graduate degree is a plus. 8-10 years related experience in the medical device industry required to include 4 -5 years experience in Post-market Surveillance, and/or Clinical Research, and/or Quality and/or other related fields. 3-5 years demonstrated leadership skills in a management capacity also required.
Knowledge of BSC complaint handling and reporting procedures and systems is preferred. Possession of clinical knowledge and background to perform as department resource for assessment of incidents is a plus.
Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings
