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

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Senior Quality Systems Specialist

At Boeing, we innovate and collaborate to make the world a better place. We’re c...

Location

United States , Hazelwood; Seattle; Jacksonville; San Antonio; Atlanta; Mesa; Philadelphia

Salary:

117300.00 - 170200.00 USD / Year

Boeing

Expiration Date

June 07, 2026

Requirements

3+ years of experience working with and supporting Quality Management System (QMS)
1+ years of experience working with Safety Management Systems
3+ years of experience leading through influence and partnering with cross-functional teams on projects, transactions or initiatives
1+ years experience developing presentations for and presenting to executive leadership
3+ years of experience collecting, organizing, synthesizing, and analyzing data, summarizing findings, developing conclusions and recommendations from appropriate data source
Capable to travel 25% of the time

Job Responsibility

Schedule, plan and lead internal Quality Management System audits for process compliance and adherence to the AS9100 Quality standard
Schedule, plan and lead process surveillances for procedural compliance
Analyzes Quality incidences, internal / external audit findings, and customer issues to determine product risks and implement mitigation plans
Ability to apply Systems Thinking and make recommendations for Quality Management System improvements and efficiencies
Represents the Company on industry working groups to develop industry standards for Quality Management and Safety Management Systems
Advises senior leadership on development of Quality Management System improvements, overall health, and streamlining opportunities
Advises multi-function groups on development of processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed
Consults in high level reviews of corrective actions at the enterprise and customer level to assure that trends or systemic issues are identified and advises on development and implementation of preventive or corrective actions
Conducts research, compiles and analyzes performance reports and data to continuously improve Quality processes
Lead and provide oversight of the BGS Quality Risk Management process to identify and mitigate Quality risks across the entire BGS network

What we offer

competitive base pay
variable compensation opportunities
health insurance
flexible spending accounts
health savings accounts
retirement savings plans
life and disability insurance programs
paid and unpaid time away from work
generous company match to your 401(k)
industry-leading tuition assistance program pays your institution directly

Fulltime

Director of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs leads the global QA/RA function a...

Location

United States , Burlington

Salary:

170000.00 - 180000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, technical, or related discipline
advanced degree preferred
8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience
5+ years of experience with Class I and/or Class II medical devices
Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls
Experience managing Quality Management Systems (QMS) for medical devices
Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred)
Demonstrated experience leading QA/RA teams, including talent development and performance management
RAC certification or equivalent is preferred

Job Responsibility

Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
Contribute to the development and lead execution of the Quality strategy
Lead departmental planning and budgeting, optimizing resources and operational efficiency
Direct QA/RA staff, including organizational design, talent development and performance management
Develop and continuously improve quality programs, policies, and processes
Ensure Quality Management System (QMS) processes are established, implemented, and maintained
Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
Oversee development and execution of global regulatory strategies for product submissions and lifecycle management

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Quality Manager – Regulatory Surveillance

We are seeking a self-starting, dynamic Senior Quality Manager to lead regulator...

Location

United States , Boston

Salary:

75.00 - 82.75 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, operations research, operations management, or related field
Typically 6+ years of relevant experience or equivalent combination of education and experience
Strong facilitation, organization, communication, and influencing skills
In-depth knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make risk-based decisions
Proven ability to identify and analyze performance indicators
Technical expertise in regulatory compliance, inspections, and quality systems

Job Responsibility

Triage and assess regulatory surveillance items, including new regulations and guidance
Lead cross-functional teams to evaluate the impact of regulations on quality systems and processes
Provide guidance on regulatory expectations, standard industry practices, and implementation options
Support inspection and submission readiness by tracking, reporting, and communicating progress
Present KPIs and metrics to stakeholders to highlight status, risks, and performance

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

Director of Quality

X-Bow Systems is hiring a Director of Quality to lead, manage, and run Quality f...

Location

United States , Luling

Salary:

200000.00 - 275000.00 USD / Year

X-Bow Systems

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or a related technical field
10+ years of progressive quality leadership experience in defense, aerospace, propulsion, energetics, or another highly regulated manufacturing environment
5+ years of experience as a people manager leading quality teams at the senior manager or director level, with direct supervisory responsibility for a meaningful-sized organization rather than a small team of individual contributors
Deep knowledge of AS9100, ISO 9001, audit systems, corrective action, nonconformance control, supplier quality, and configuration-controlled manufacturing
Experience supporting U.S. government contracts and operating in highly regulated production environments
Strong understanding of inspection systems, process validation, first article inspection, traceability, and risk-based quality management
Proven ability to lead root cause investigations, drive corrective action, and improve quality performance in complex technical operations
Strong leadership, judgment, and cross-functional influence, with the ability to lead through managers and supervisors and hold teams accountable across functions and locations
U.S. Person status and ability to obtain or maintain any required security clearance or access authorization
Master's degree in Engineering, Operations, Quality, or Business Administration

Job Responsibility

Lead the company's quality organization across quality assurance, quality control, supplier quality, audit readiness, nonconformance management, and corrective action
Set quality strategy, objectives, and performance expectations aligned with operational goals, customer requirements, and company growth
Advise the COO and executive leadership on quality risks, systemic issues, compliance gaps, and improvement priorities
Own and maintain the Quality Management System across relevant operations, facilities, and programs
Ensure compliance with AS9100, ISO 9001, customer requirements, contract flow-downs, and applicable FAR/DFARS requirements
Lead internal, customer, third-party, and regulatory audit activity and maintain audit readiness
Ensure effective controls for documentation, traceability, inspection, testing, calibration, configuration control, and records retention
Lead receiving, in-process, and final inspection strategies to ensure product conformity and process discipline
Own nonconformance, containment, root cause, corrective action, and verification of effectiveness across internal and supplier issues
Improve quality performance using metrics including yield, escapes, rework, scrap, supplier defects, audit findings, and cost of poor quality

Fulltime

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

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Senior Quality Manager – Regulatory Surveillance

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