Apply on Employer Site

Bracco Medical Technologies · 14 hours ago

Sr. Quality Systems Specialist

Twin Cities Area

Full-time

Hybrid

Mid, Senior Level

$120K/yr - $130K/yr

5+ years exp

Bracco Medical Technologies is focused on fostering a supportive work environment for its employees. The Senior Quality System Specialist will develop and maintain a robust quality system in compliance with relevant standards and regulations, while leading projects to enhance the quality management system and ensuring compliance with external standards.

ManufacturingMedicalMedical Device

Comp. & Benefits

Hiring Manager

Shiksha Shubham

Responsibilities

Initiate, facilitate and/or manage projects to expand, enhance and improve the quality system

Create, review and maintain quality system SOPs, work instructions and other documents

Act as liaison for global corporate QMS with counterparts from other facilities

Support Notified Body audits, customer/partner audits and FDA inspections

Provide quality system training for the organization

Lead special projects to enhance and extend the effectiveness of the QMS

Support or coordinate field action investigations and related activities

Facilitate the creation and assignment of training requirements within the Learning Management System

Manage document change control within our PLM system

May supervise or provide work direction, training, and mentoring for junior team members

Monitor the release of new standards that may affect Product or the Quality Management System

Lead efforts to ensure compliance of emerging standards and regulations

Conduct gap assessments of new regulations and standards, and drive resolution of the gaps to ensure ongoing QMS and Product Compliance

Coordinate with Regulatory and other teams to communicate and educate staff on emerging standards that may affect the QMS and the business

May lead the External Standards Review Board, as assigned

Serve as a Lead Auditor for internal audits at the corporate site

Support internal audits and supplier audits at domestic and international sites

Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions

Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities

Work with SME’s to ensure audit record content is accurate, well documented, and meets the requirement of the process

May lead the Corporate Internal Audit Team, as assigned

Ensure that all CAPAs are entered into the CAPA system, assigned to the appropriate personnel, and completed according to CAPA procedures and within specified time periods

Develop metrics and perform trend analysis of the CAPA process to identify areas for improvement

Mentor and coach CAPA owners toward effective investigation and root cause analysis, resulting in CAPA content that is accurate, well documented, meets the requirement of the process, and is completed in a timely manner

Own and lead Quality Management System CAPAs, as needed

May lead the corporate CAPA Board, as assigned

Qualification

Quality Management SystemsFDA QSR/QMSRISO 13485EU Medical Device RegulationLead Auditor certificationOrganizational skillsProblem-solving skillsCommunication skillsTeam collaboration

Required

Bachelor's degree required

5+ years medical device experience including at least 3 years in Quality Management Systems

Strong knowledge and hands-on experience with FDA QSR/QMSR, ISO 13485, EU Medical Device Regulation (MDR), and other national and international regulations (Canada, Japan, China, Brazil, etc.)

Able to build relationships and work effectively with individuals at all levels of the organization in a collaborative and congenial manner

Ability to clearly and concisely articulate ideas both verbally and in writing

Proven organizational skills, planning skills and ability to work effectively within teams

Proven ability to take initiative and ownership in order to move projects or tasks forward to completion

Ability to shift priorities based on the current business needs and to make progress on multiple, concurrent projects

Independent decision-making and problem-solving skills; ability to analyze information, evaluate results and choose the best solution

Preferred

Experience with EU MDR assessment and implementation

Experience supporting field action activities

ISO 13485 Lead Auditor certification

Benefits

Paid Time Off, Company Holidays & Paid Family Leave

Annual incentive plan and 401k savings plan contributions

Comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.

Structured on-the-job learning, workshops, seminars, and our tuition reimbursement program