Qualcomm Manager, Quality Assurance in Andover, Massachusetts
Manager, Quality Assurance
Qualcomm Life, Inc.
Life at http://www.qualcomm.com/solutions/healthcare
Engineering - Manufacturing/Quality/Other
Massachusetts - Andover
Capsule, a Qualcomm Life company, is a global market leader dedicated to capturing, harnessing and unlocking the power of data from all medical devices found throughout a health care enterprise. Capsule is focused on medical device connectivity and data management and empowers medical device manufacturers to deliver data quickly and easily to those who need it.
Reporting to the Director of Quality and Regulatory, youll collaborate with team members located in Paris, San Diego and Andover, MA to ensure quality integration into the overall functions of design, development and process. This is a hands-on role (no direct reports), leading quality assurance across the organization. This position is located in Andover, MA.
Develop and implement quality system strategies that maintain high standards of quality, reliability, security, privacy and safety.
Ensure that design control procedures are effectively implemented.
Ensure that CAPA, complaint, supplier quality, training, quality management review and other quality processes are effectively implemented.
Ensure that risk management systems are effectively implemented.
Perform supplier quality audits.
Support regulatory and internal audits.
Monitor key performance indicators and quality metrics.
Provide software quality assurance support in design and development of software and hardware solutions.
Ensure that development projects and changes to existing systems are conducted in compliance with 21 CFR Part 820 FDA Quality System Regulation and Medical Device Directives.
All Qualcomm employees are expected to actively support diversity on their teams, and in the Company.
7+ years of Quality Engineering or Quality Assurance experience in the medical device industry.
3+ years leading/participating in regulatory inspections and audits.
3+ years of experience in medical device software quality and computer system validation.
Working knowledge of the 21 CFR Part 820 FDA Medical Device Quality System Regulation, ISO 13485, ISO 14971, EN 62304 and the Medical Device Directives
10+ years Quality Engineering or Quality Assurance experience or related work experience
Experience with ISO 27001, cyber security, and privacy (HIPAA)
Experience with Medical Device Data Systems (MDDS)
Lead auditor training and certification
ASQ CQE, CRE, CQA or CSQE Certification
Lean 6-sigma Green or Black Belt Certification
3+ years experience working in a large matrixed organization
2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above)
Required: Bachelor's in Engineering and/or Life Sciences or related field
Preferred: Master's in Engineering and/or Life Sciences or related field
EEO employer: including race, gender, gender identity, sexual orientation, disability & veterans status.