Senior Quality Management Systems Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee global QMS governance, harmonization, and ongoing enhancement across various sites and functions.

• Direct regulatory and standards monitoring, conduct gap analyses, and implement any new or updated requirements.

• Manage CAPA governance, change management processes, document control, training, Management Reviews, and quality metrics.

• Supervise the Supplier Quality Program, which includes supplier qualification, monitoring, performance evaluation, SCARs, and risk assessment.

• Head the Internal Audit Program, encompassing audit planning, auditor qualifications, execution, reporting, and follow-up actions.

• Spearhead the implementation and optimization of electronic QMS and Document Control systems within the ERP/eQMS landscape.

• Provide Quality oversight for the assurance/validation of computer software that impacts quality.

• Propel QMS performance, inspection preparedness, and continuous improvement by utilizing metrics, trends, and risk-based decision-making.

• Act as a senior QMS subject matter expert during FDA, Notified Body, MDSAP, certification, and customer audits.

• Manage quality processes that support customer information requests and change notifications.

• Lead, mentor, and develop the QMS team while collaborating with site and functional leadership to enhance Quality System effectiveness.

⛳️ Requirements

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related technical field.

• Over 10 years of Quality experience within the medical device or regulated life sciences sector.

• More than 5 years of experience leading QMS programs or significant Quality System initiatives.

• At least 5 years of experience in people management.

• Advanced understanding of ISO 13485 and FDA QMS requirements for medical devices.

• Familiarity with global regulatory requirements, regulatory/standards gap assessments, and QMS implementation.

• Extensive experience with core QMS processes and governance of Supplier Quality Programs in a manufacturing context.

• Background in regulatory inspections, Notified Body audits, MDSAP, and/or certification audits.

• Proven capability to lead complex, cross-functional, and multi-site projects.

• Strong skills in leadership, analytics, communication, technical writing, and problem-solving.

• Experience with global or multi-site medical device QMS.

• Knowledge of EU MDR and medical device regulations in Canada, Australia, Brazil, Japan, Switzerland, and the UK.

• Experience with eQMS/ERP Quality systems, software assurance/validation, and ISO 14971 risk management.

• Preferred certifications include Lead Auditor, ASQ CMQ/OE, CQA, RAC, or equivalent.

🏝️ Benefits

• Medical insurance

• Prescription drug insurance

• Dental insurance

• Vision insurance

• Flexible spending accounts

• Participation in 401(k) savings plan

• Paid time off (PTO)

• Short-term disability

• Long-term disability

• Parental leave