Quality Systems Manager

JOBTITLE: Quality Systems Manager

LOCATION: 50 Northern Ave. Boston Massachusetts 02210

OPENINGS: 1

DUTIES:

• Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues ensuring compliant and efficient solutions.

• Draft review andmaintainprocess-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure theyremaincompliant and up to date.

• Analyze workflows quality systems and production processes toidentifyinefficiencies compliance gaps and areas for continuous improvement.

• Develop and implement effective solutions encompassing enhancements to cross-functional quality systems and operational processes ensuring adherence to industry standards and regulations including 21 CFR Parts 4 and 820 ISO 13485 and ISO 14971.

• Participate as a technical resource in cross-functional teams providingexpertisein quality investigations deviations and operational issues.

• Conduct thorough root cause analyses and product impact assessments for investigations resulting from deviations OOS or operational inefficiencies and propose corrective and preventive action plans (CAPAs).

• Approve investigationsCAPAs andchange controls andassistChange Control owners in ensuring compliance with change procedure requirements.

• Support vendor quality management activities including evaluating vendor quality systems and assisting in resolving vendor-related quality issues.

• Design and implement metrics and reporting systems using tools including Power BI to analyze dataidentifytrends and guide decision-making.

• Drive continual improvement initiatives through Lean Six Sigma and other quality and operational methodologies.

• Developmaintain and deliver training curricula for team members providing guidance on compliance quality standards and operational best practices.

• Identifyrisks in quality systems and production processes communicate them effectively to stakeholders andassistwith risk mitigation plans.

• Coordinate and follow up onmanagementactionitems andensuretimelycompletion of assigned tasks.

REQUIREMENTS: Employer will accept aBachelorsEngineering Life Sciences Industrial and Technical Studiesor a related field and5years of experience in the job offered or inQuality Systems Manager-related occupation.

Position requires demonstrable experience in the following:

A minimum of 3 years of experience in the medical devices field.

In-depth knowledge of both the conceptual and practical application ofcGMPsin a medical device setting as well as knowledge of global GMP requirements and the ability to provide quality oversight guidance and compliance support to GMP manufacturing operations.

In-depth experience leading complex projects and teams and continuous improvement initiatives within statedobjectivesand timelines; effectively apply project management processes and tools to plan deliverables track progress lead project meetings and ensuretimelycompletion of milestones.

Facilitate collaboration between departments and setting clear quality expectations during risk-based decision making effectivelyrepresentingthe Quality unit.

Experience leading event investigations Root Cause Analysis (RCA) and corrective and preventive action plans (CAPAs).

Experience working with electronic management systems including Veeva to manage workflows related to document management systems including SOPs and Work Instructions. Experience examining deviations and CAPA processes to ensuretimelyreview and closure.

Rate ofPay: $134202.00- $164400.00

CONTACT: Send Resume tofuturetalent@.Reference12140.619. EOE.

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