Regulatory Quality Assurance Manager Job at Alliance Medical Ltd (Guildford)

Manager, Regulatory Affairs & Quality Assurance

NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Q...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances
Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards
Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485)
RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred)
A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals

Job Responsibility

Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification
Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are “FDA-cleared.”
Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls
Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators
Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671)
Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements
Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment
Partner with product development and commercial teams to navigate registration processes and ensure timely product launches

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...

Location

Singapore

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific or technical discipline
6-10 years of experience in the medical device industry
Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
Strong written and verbal communication skills
Experience with regional or international regulatory submissions preferred
Strong computer proficiency
Understanding of regulatory requirements across major APAC markets
Familiarity with mandatory Quality Management System requirements across APAC
General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage

Job Responsibility

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
Provide Regulatory and Quality leadership across all APAC markets
Recruit, build, and develop in-country RA/QA teams
Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
Maintain regulatory databases
Direct the development and maintenance of regulatory systems and processes
Develop APAC regulatory strategies

What we offer

comprehensive and competitive range of benefits
health care benefits
retirement plans
work/life benefits

Senior Manager Quality Assurance: Incoming Quality and Warehouse

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , New Albany

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
Master's degree and 6 years of Quality/Manufacturing/Engineering experience
Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Lead and participate in Quality Risk Assessments
Provide Quality input to support project or operational design decisions
Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

New

Sr Manager, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

New

Quality Assurance Regulatory Affairs Coordinator

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proactive and able to manage multiple priorities effectively
Comfortable working in a fast-paced, regulated environment
Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease

Job Responsibility

Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
Create and maintain training materials, ensuring accurate and up-to-date training records across the business
Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
Support the development, implementation, and continuous improvement of QARA strategies and the QMS
Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact

Fulltime

New

Sr Manager, Quality Assurance

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required
5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience
FDA regulated manufacturing experience preferred
Six Sigma Green Belt Certification or industry-standard equivalent preferred
Project Management skills and experience are preferred
Experience and skills in Lean Manufacturing are preferred
Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.

Job Responsibility

Lead quality oversight for the Devices areas
Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies
Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement
Ensure product compliance through established inspection criteria and procedures
Coordinate inspection activities throughout the production cycle
Analyze statistical data and product specifications to determine and improve quality standards
Prepare and submit reports to Managers and other Departments or Agencies as required
Communicate quality philosophy to key personnel
Actively participate in quality management teams within the organization
Manage and support area associates, encouraging a teamwork environment

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality Assurance Manager

The Quality Assurance Manager is responsible for supporting compliance, safety, ...

Location

United States , Lansing

Salary:

Not provided

Aramark

Expiration Date

Until further notice

Requirements

Bachelor's degree preferred in Business, Hospitality, Safety, Engineering, Operations, Environmental Management, or a related field
equivalent experience considered
3–5 years of experience in quality assurance, compliance, facilities administration, operations support, project coordination, or a related field preferred
Strong organizational and project management skills with the ability to manage multiple priorities simultaneously
Strong interpersonal and communication skills, with the ability to work effectively with both technical and non-technical stakeholders
Ability to interpret contracts, regulatory requirements, policies, and operational procedures
Experience preparing reports, maintaining records, and tracking compliance-related documentation
Demonstrated ability to identify issues, analyze data, and develop practical solutions
Working knowledge of preventive maintenance practices, facilities operations, or asset management systems preferred
Experience with CMMS, compliance tracking, or facilities management software preferred

Job Responsibility

Support property-wide compliance with Aramark standards and applicable federal, state, and local regulations
Coordinate and track required licenses, permits, inspections, certifications, and regulatory reporting obligations
Maintain documentation and records associated with compliance activities, including audit readiness and retention standards
Establish and support recurring internal audit processes and corrective action tracking
Remain current on applicable laws, regulations, and operational requirements impacting the business
Partner with department leaders to ensure Quality Assurance (“QA”) assessments, waste tracking, and related reporting are completed accurately in GMM and other required systems
Implement and maintain department-level Standard Operating Procedures (“SOPs”) through process review, documentation, and ongoing evaluation
Identify operational gaps, process inefficiencies, or non-conformance issues and help develop corrective action plans
Assist in developing reports, dashboards, and tracking tools that support operational performance and compliance visibility
Serve as MS3 Administrator and maintain the MS3 Master Scheduler and Facility Library systems in partnership with Performance Excellence and Project Management teams

Fulltime

Quality Assurance Manager

This is a FlexSteel position and is located in Baytown, TX. FlexSteel (www.flexs...

Location

United States , Baytown

Salary:

Not provided

Cactus Wellhead LLC

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferred
10 years of experience in Manufacturing environment required
5 years of experience in a Quality leadership role required
Experience in Oil & Gas industry preferred
Pre-employment drug screening
Background checks
Medical examinations
Safety certifications
Valid driver's license
Ability to wear personal protective equipment (PPE)

Job Responsibility

Own and maintain the local Quality Management System(QMS) ensuring continued compliance to ISO, API and applicable industry standards
Maintain regulatory compliance with all applicable federal, state and local agencies
Serve as the primary point of contact for internal, and accreditation audits, coordinating audit activities and ensuring successful outcomes
Champion company Quality initiatives and programs and promote excellence in Quality performance
Ensure that Procedures, Specifications and Work Instructions are current, represent best practices and are consistent with the company Quality Management System
Oversee Document Control processes and provide review/approval where required
Provide leadership in ensuring all operations and activities follow company Quality policies and procedures
Maintain Quality metrics and support company reporting mechanisms
With the HSE Manager, facilitate equipment and/or design Risk Assessments and ensure that controls and preventative measures are properly implemented and verified
Willingness to challenge existing processes and escalate quality concerns

Fulltime

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Regulatory Quality Assurance Manager

Job Description

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