Senior Quality Manager – Regulatory Surveillance Job at Connexion Systems & Engineering, Inc (Boston)

Senior Director of Quality

HPE is seeking a strategic, customer-focused Senior Director of Quality to lead ...

Location

United States

Salary:

161000.00 - 389500.00 USD / Year

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, quality assurance/quality management, or a related field. Master’s degree preferred
10+ years of progressive quality leadership experience, including 5+ years in a senior leadership role managing global teams across hardware, software, and services
Proven experience within complex products and complex supply chains
prior experience in HPC, AI, networking, storage, or comparable high-tech industries encompassing one or more quality management domains is preferred
Proven ability to build and scale QMS and quality programs within complex organizations
Deep knowledge of quality systems, methodologies and tools (Six Sigma, Lean, APQP, FMEA, risk management, root cause analysis). Strong problem-solving and data-driven decision-making skills
Experience with regulatory standards and certification processes (ISO, industry specific)
Experience with supplier quality management, including supplier qualification, audits, and remediation
Proficiency in quality management software and enterprise systems
Strong leadership and people management abilities

Job Responsibility

Define and drive the business unit’s quality strategy, standards, and metrics to ensure product quality, regulatory compliance, and customer excellence
Lead and advance the Quality Management System (QMS), including document control, change control, CAPA, nonconformances, deviation handling, and supplier quality management
Lead, mentor, and develop a high-performing, cross-functional Quality organization by setting clear objectives, tracking performance, developing talent, and fostering a quality-first culture
Collaborate with Product & Engineering leadership to influence design for reliability, testability, manufacturability, and serviceability. Ensure design quality, implement design controls, conduct DFM/DFMEA, participate in design reviews, and develop verification and validation strategies
Ensure compliance with applicable regulations and standards such as FDA, EMA, ISO 9001, ISO 13485, GMP, and GMP-like requirements. Coordinate internal and external audits, inspections, regulatory submissions, and remediation activities
Partner with Supply Chain and Procurement to manage supplier quality, including qualification, performance management, corrective actions, and continuous improvement
Own root cause investigations for systemic quality issues, lead cross-functional corrective actions and verification of effectiveness
Lead risk management activities including FMEA and risk assessments, conduct product safety evaluations, and oversee post-market surveillance to proactively manage risk
Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance quality, yield, throughput, and customer satisfaction. Manage quality-focused kaizen events and project portfolios
Prepare and present quality metrics and reports to senior leadership, translating data into actionable insights and strategic recommendations

What we offer

Health & Wellbeing
Personal & Professional Development
Unconditional Inclusion

Fulltime

ISO Quality Compliance Manager

We are seeking an experienced and detail-oriented ISO Quality Compliance Manager...

Location

Pakistan , Rawalpindi

Salary:

Not provided

Translation Empire

Expiration Date

Until further notice

Requirements

Deep understanding of ISO standards (e.g., ISO 9001, ISO 27001, ISO 14001)
Extensive experience in auditing, quality management systems (QMS), and regulatory compliance
Experience in [Insert Industry, e.g., Manufacturing, IT, Healthcare, etc.]
Knowledge of other standards like ISO 45001, GDPR compliance, or sector-specific regulations
Experience with risk management and business continuity planning

Job Responsibility

Manage and ensure ongoing compliance with ISO standards (e.g., ISO 9001, ISO 27001, ISO 14001)
Lead and coordinate ISO certification, surveillance, and recertification audits
Develop, implement, and maintain the company’s Quality Management System (QMS) in alignment with ISO and regulatory requirements
Review and update quality policies, procedures, manuals, and process documentation regularly
Plan, organize, and conduct internal and external audits
ensure timely closure of non-conformities
Identify gaps and areas for improvement
lead corrective and preventive action plans (CAPA)
Deliver ISO standards and compliance-related training and awareness programs to employees
Promote a culture of quality, compliance, and continuous improvement across all departments

Fulltime

New

Manager, Quality Management System

As the leader of our Quality Management System at Archer, you will play a pivota...

Location

United States , San Jose

Salary:

117500.00 - 155600.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering (Aerospace, Mechanical, Electrical, or Industrial) with at least 7+ years’ experience leading quality teams within aerospace or other regulated industry
Experience hiring, leading and managing salaried & hourly employees
Experience overseeing and implementing AS9100 certification with an in-depth understanding of AS9102, AS9103, and AS9145
Direct experience establishing and leading CABs and supporting MOR quality reviews with senior leadership
Experience leading all aspects of quality to include: QMS (Quality Management System)
Auditing (Internal & External)
3rd Party Certification, Receiving Inspection
In-Process Inspection
Product Quality Engineering
FMEA (Failure Mode Effects Analysis) implementation

Job Responsibility

Author, maintain, and continuously improve the QMS (Quality Manual, procedures, work instructions) ensuring full compliance with AS9100 and FAA 14 CFR § 21.137 Quality System requirements across all Archer sites
Serve as the primary quality liaison with the FAA during Production Certification, supporting conformity inspections, and airworthiness certificate issuance activities
Establish and govern a unified QMS framework across multiple sites, including standardized audit programs, cross-site corrective action processes, and site-level quality leadership structures
Lead internal and external audits with AS9100 third-party certification body and FAA surveillance audits across all sites
Own the Corrective Action Board (CAB) and Root Cause Corrective Action (RCCA) process to drive systemic resolution of nonconformances across all sites
Define and report KPIs to senior leadership via Monthly Operations Reviews (MOR) and real-time dashboards
Integrate quality into Engineering, Manufacturing, Supply Chain, and Flight Operations processes
Partner with Archer Certification and Safety Department on SMS and Type Certificate obligations
Manage QMS budget and a geographically dispersed quality team

Fulltime

Senior Healthcare Regulatory Specialist (SaMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

Gipo

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – vacation, birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment
Flexibility That Works for You – Remote work and flexible hours

Fulltime

Senior Healthcare Regulatory Specialist (SaMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

DocPlanner GmbH

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
ESOP (Employee Stock Option Plan) after 6 months
Local Perks – depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment
Flexibility That Works for You – Remote work and flexible hours
Office access at hubs in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna

Fulltime

Senior Healthcare Regulatory Specialist (saMD)

The Risk & Compliance team ensures Docplanner meets regulatory requirements whil...

Location

Spain , Barcelona

Salary:

Not provided

DocPlanner GmbH

Expiration Date

Until further notice

Requirements

Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context
Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks
Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience
Experience with EUDAMED, CAPA systems, and post-market surveillance tools
Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders
Strong communication skills with both internal teams and external regulatory authorities
Fluent in English
Spanish or other EU languages are a plus

Job Responsibility

EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access
Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance
Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers
Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry

What we offer

Healthcare insurance
Wellness that works for you – from gym memberships to mental health support
Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge
ESOP (Employee Share Option Plan) after 6 months
Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave
Career Growth – lots of chances to learn, develop, and explore new paths
A Truly Global Team – Work with talented people from all over the world
Flexibility That Works for You – Remote work and flexible hours

Fulltime

Compliance Testing Senior Officer - Equities & Spread Products

Serves as a senior compliance risk officer for Independent Compliance Risk Manag...

Location

United Kingdom , London

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Extensive experience in Compliance Testing
Expertise in Equities and/or Spread Products
Expertise of Compliance laws, rules, regulations, risks and typologies
Extensive experience in planning, executing, and reporting on compliance testing reviews and regulatory issue validation activities for global businesses/programs
Knowledge and extensive experience with auditing principles including audit planning, risk assessments, development of risks and controls matrices, processes and controls design assessments, controls operating effectiveness testing, transactional access segregation of duties, transactional testing, surveillance systems, and reporting activities
Demonstrated career progression within highly respected diversified institutions with complex and diverse products and customers
Understanding of rules, laws, and regulations, and specific regulatory requirements impacting financial services
Strong interpersonal skills for building strong relationships with stakeholders and engaging teams
Effectiveness in working within a large scale and complex matrix organization is essential
Excellent oral communication and writing skills in interacting with non-executives and executive management and across a number of business lines and control functions

Job Responsibility

Developing, implementing, and executing compliance testing, continuous testing, and reporting programs in accordance with the Compliance Independent Assessment (CIA) Plan
Participating in the planning, executing, and reporting of compliance testing reviews and compliance and regulatory issue validation activities for a component of a product line, function, or legal entity in accordance with CIA Plan
Serving as a lead reviewer for complex reviews, analysing report findings, and communicating findings to corresponding control/process owners
Ensuring the timely delivery of high quality, value-added testing reports for a portfolio of business activities, which meet the requirements of the Boards of Citigroup and Citibank, their affiliates, and of Citi’s respective regulators, globally
Utilizing innovative compliance testing solutions including Data Analytics to increase value and reduce costs of compliance-related activities
Developing effective relationships within CIA function and with other stakeholders including Business process owners, Risk management and Internal Audit function
Identifying industry best practices and share insight with the CIA teams on a regular basis
Informing CIA management of significant compliance matters that require their attention or action

Fulltime

New

Senior Regulatory Affairs Specialist – Regional

This role offers an exciting opportunity to provide regional regulatory support ...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Pharmacy, Science, or equivalent
Minimum 6 years of regulatory experience in the medical devices industry
Strong expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above
In‑depth knowledge of regulatory laws, acts, and evolving requirements
Solid understanding of GDPMD standards
Skilled in project management, multitasking, and prioritization
Excellent interpersonal, communication, and negotiation skills
Proficiency in technical systems (word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate effectively

Job Responsibility

Develop and execute regulatory project plans that keep products moving efficiently through approval pathways
Identify and escalate regulatory risks early, ensuring proactive solutions
Stay ahead of evolving regulations and translate requirements into clear, actionable steps
Maintain accurate and compliant regulatory files and documentation
Actively contribute to project teams, offering practical regulatory guidance
Respond to inquiries from regulatory authorities within strict timelines
Compile, prepare, and submit new registrations, variations, renewals, and change notifications to secure timely approvals
Review and approve labeling and promotional materials to ensure compliance with local regulations
Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards
Manage post‑market surveillance (PMS), field actions, and complaints in Singapore and Malaysia

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Quality Manager – Regulatory Surveillance

Connexion Systems & Engineering, Inc

Location:
United States , Boston

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 13, 2026

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