Senior Quality Assurance Auditor Job at 360 Resourcing Solutions (Downpatrick)

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

Senior Quality Assurance Engineer

Job title - Senior Quality Assurance Engineer. Duration - 12months initial. Star...

Location

United Kingdom , Whitehaven or Sellafield

Salary:

Not provided

Rullion

Expiration Date

Until further notice

Requirements

Quality Assurance Understanding (ISO 9001:2015, Contractor Quality Requirements SLM 4.06.02)
Mechanical / Electrical / Civil Engineering understanding
Internal Auditors
ISO 9001:2015 Lead Auditor
Degree (2:2 minimum) in relevant discipline OR professional qualification (e.g. CQI Diploma (Level 5))
Professional Body Membership CQI or working towards
Relevant extensive Quality Assurance experience

Job Responsibility

Production, review and endorse as appropriate Quality Plans and Inspection and Test Plans
undertaking associated compliance verification activities as appropriate
Liaise with Quality Control and ICG where required to ensure verification of processes and relevant documentation ITP's, weld procedures etc
Ensure the quality standards of the Project are consistently met, raising the authorised project documentation where this is not the case
Review and update IMS as required
Maintenance of package status & progress reporting, raising issues and liaising with the project and client QA/QC team
Support Internal and External Audits - track actions arising, so that systems can be improved and so that non-compliances are reduced
Advise project purchasing staff on the competence of vendors, so that QA matters may be taken into account when selecting vendors
Initiate Quality Grade Risk Assessment Meetings

Fulltime

Senior Engineer, Quality Assurance Engineering

As a member of the SSD Quality & Reliability Engineering team, you will leverage...

Location

Malaysia , Batu Kawan, Penang

Salary:

Not provided

Sandisk

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s Degree in Science or Engineering
Preferred 3+ years of experience in high-volume manufacturing or engineering environments
Proven track record of successfully delivering projects in globally distributed, cross-functional teams
In-depth understanding of storage systems, including key aspects such as performance, quality, and reliability
Hands-on experience in testing, reliability, and endurance evaluation of Flash memory and storage solutions
Background as an ISO 9001 auditor and holder of a Six Sigma Green Belt would be an added advantage
Highly objective-driven and results-oriented
Strong knowledge of FMEA, 8D methodology, and Statistical Process Control (SPC)
Proficient in Microsoft Office, statistical analysis software, and issue tracking tools such as JIRA
Excellent interpersonal, communication, leadership, critical thinking, and problem-solving skills

Job Responsibility

Represent product quality as the Sustaining Program Manager in core teams, ensuring alignment with quality and reliability goals throughout the product lifecycle
Accountable for product quality and reliability when product transitions into sustaining phase
Drive activities to ensure that product quality & reliability expectations are met
Lead the resolution of quality-related issues during both New Product Introduction (NPI) and Sustaining phases
Communicate quality excursions to executive management and core teams
Lead Stop Ship and Quality Alert Critical processes, driving closure through risk assessment, containment actions, 8D root cause analysis, CAPA, and lessons learned
Collaborate with NPI counterparts to ensure seamless product transition into Sustaining, meeting all product, customer, and regulatory requirements
Participate in new product kick-off reviews and Manufacturing Readiness Reviews (MRRs)
Coordinate with other QAPMs to share lessons learned and support continuous process improvement across programs

Fulltime

Senior Technology Quality Auditor

Technology Auditors possess significant authority and decision-making power with...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred.

Job Responsibility

Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines
Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
Travel internationally for audits, as required
Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
Review audit reports, responses and other program deliverable to ensure consistent high quality
Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities

Senior Food Safety and Quality Assurance Manager

We are seeking a highly specialized, results-driven Senior Food Safety & Quality...

Location

United States

Salary:

90000.00 - 140000.00 USD / Year

American Food & Vending

Expiration Date

Until further notice

Requirements

Bachelor’s degree in food science, Public Health, Environmental Health, or a related field
Advanced degree and/or professional certifications preferred
Experience within the dining and refreshment sector (casual dining, quick-service, catering, events, or hospitality)
Lead Auditor certifications (ISO 22000, HACCP, SQF) or extensive internal auditing experience
Strong supplier quality management and vendor qualification experience
Knowledge of sanitation validation, environmental monitoring, and comprehensive allergen control programs
Familiarity with ERP systems and QA data integration beyond Salesforce
Experience supporting complex supply chains, international operations, or multi-brand portfolios
Demonstrated, hands-on experience with FDA, HACCP, SQF, DOT, NFPA, OSHA, and GMP requirements
Proven ability to interpret regulations and apply them to complex, multi-site operations

Job Responsibility

Design, implement, and maintain comprehensive food safety and quality assurance programs across multi-site dining and refreshment operations
Ensure compliance with applicable regulations and standards, including FDA (FSMA, GMPs, recalls, labeling), HACCP, SQF, DOT, NFPA, OSHA, and GMPs
Lead the development, validation, and optimization of HACCP plans, prerequisite programs (PRPs), sanitation programs, allergen control plans, and environmental monitoring programs where applicable
Maintain robust documentation control, versioning, and recordkeeping systems to support FDA, SQF, and GMP compliance, including change control and regulatory reviews
Conduct internal audits, supplier audits, third-party assessments, and mock recalls
Lead regulatory due diligence, risk assessments, gap analyses, CAPA development, remediation activities, and effectiveness verification through revalidation and follow-up audits
Oversee recall readiness, crisis management protocols, mock recalls, and business continuity planning
Monitor evolving regulatory requirements (FDA, OSHA, DOT, NFPA) and translate updates into actionable program enhancements
Lead food safety and occupational safety incident investigations, including root-cause analysis, containment, corrective and preventive actions, and verification activities
Promote a proactive food safety and workplace safety culture through continuous improvement initiatives and cross-functional engagement

What we offer

Weekly Pay
401K with match
Employee Assistance Program
Eligible employees offered Medical, Prescription, Dental, and Vision Plans
Learning and advancement opportunities

Fulltime

Senior Quality Engineer

To make sure that work is carried out to the customer’s standards, specification...

Location

United Kingdom , Cumbria

Salary:

Not provided

Morgan Sindall Plc

Expiration Date

Until further notice

Requirements

Trained Internal or Lead Auditor to ISO 9001 (desirable)
Practioner/Member of the CQI or working towards Practioner level as a minimum
Good management skills, with experience of managing a team, with the ability to motivate self and colleagues to achieve high standards of compliance
Operational or Project experience within the Nuclear Industry or in an environment with similar complexity and risk, sufficient to understand and review end to end processes and propose quality improvements
Knowledge & background in a Civils, Structural and Architectural (CS&A) (desirable)
Previous experience with temporary works
Ability to ensure standards and specifications are met
Have a wide understanding of the industry, including knowledge of materials, trades, methods and legal requirements
Able to engage effectively with all levels of the PPP organisation, suppliers and Stakeholders, to provide coaching, education and challenge and to act as an effective interface between all parties. Relevant security clearance level to access and inspect areas of site within area of responsibility (if applicable)
Able to work collaboratively with integrated teams to prepare quality plans and inspection plans and define requirements for life time records

Job Responsibility

Develop, maintain, improve – and provide coaching on the use of – local management systems to enable effective delivery
Verifying that quality requirements are adequately specified and complied with
Ensure that the works (including materials and workmanship) are adequately specified and are carried out in accordance with contract documents/programmes and assist in the resolution of any on-site issues that may arise
Interface and engage with key stakeholders to promote a joined-up approach to quality
Assess the ability of suppliers to meet specified requirements
Engage with relevant disciplines / functions to translate requirements and expectations, taking consideration of risks and opportunities and learning from experience (LFE)
contribute to project meetings, subcontractor pre-contract and pre-start/opening up meetings
Work collaboratively with integrated teams to prepare and implement quality plans and inspection plans, including co-ordination of surveillances required to monitor quality standards in line with specifications
Review and accept relevant documentation including supply chain quality submissions
Define quality and lifetime record strategies for a project, operation, activity or contract to ensure a demonstrable audit trail that the product/service meets the required specifications

What we offer

Generous, incremental holiday entitlement with the option to buy five days
Family friendly policies and work/life approach
Mentoring programmes and continuous learning support
Contributory pension scheme
Annual bonus scheme
Recognition scheme and long service awards
Car scheme and Private Medical Insurance

Fulltime

Senior Quality Engineer

SRG are delighted to once again be working with a specialist aerospace & defence...

Location

United Kingdom , Coatbridge

Salary:

55000.00 GBP / Year

SRG

Expiration Date

Until further notice

Requirements

Certified Quality Management System auditor - AS9100 Desirable
Prior experience working to AS9100 standards
Demonstrable experience identifying and implementing process improvement
Industrial knowledge of the process and controls used in the manufacture of high reliability products
Comfortable interacting with and presenting to internal & external stakeholders

Job Responsibility

Ensure product quality and compliance against regulatory and specification requirements
Work closely with operations, manufacturing & NPI business units to assure product quality is to internal, regulatory and customer standards
Carry out internal and external audits to AS9100 standards
Review products and processes to ensure regulatory compliance & maximum efficiency
Carry out root cause analysis and corrective action against any non-conformance
Manage the AS9100 Quality Management System
Train new & existing colleagues on the QMS and QC inspections

What we offer

Fully Dayshift & Mon-Fri (Half Day on a Friday)
Opportunities for career development

Fulltime

Technology Senior Auditor

The Technology Senior Auditor participates in the timely delivery of high qualit...

Location

Kenya , Nairobi

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

University Degree (preferably IT related such as Computer Science, Information Technology)
At least 5 years of experience of auditing or managing IT infrastructure systems or applications in a medium to large scale environment, preferably in Banking and Finance field, with strong understanding of related IT risks, controls, and regulations
Specific areas of experience should include cyber risks and controls within the ICT systems and related third-party connections, cybersecurity framework, understanding of threat and vulnerability assessment tests, and penetration tests
Additionally, experience should include Desktop and Server technologies including virtualization and Cloud operations, Databases, Middleware, data and voice networks, Software Development and Production Support practices, Cybersecurity management, and the ITIL general controls processes including IT Governance and IT Program/Project Management
Demonstrated analytical ability to understand IT control issues and related risks and controls, to identify root cause and recommending solutions
Strong written and verbal communications skills in English with ability to clearly articulate issues and facilitate identification and implementation of solutions
Preferred with relevant professional qualifications such as Certified Information Systems Auditor (CISA), Certified Information Security Manager (CISM) or Certified Information Systems Security Professional (CISSP)
Preferred experience in designing or using Computer Assisted Audit Tools and Techniques (CAATTs)
Working knowledge of the modern banking technology systems
Good project management and interpersonal skills

Job Responsibility

Understand and grasp the audit methodology, corporate standards, and internal control processes and use this knowledge to execute audit reviews
Participate in technology audits by identifying key risks and controls, develop and execute control assessment plans, draft control issues and present them to the technology management, discussing practical solutions
Execute audit assignments through effective collaboration with other audit teams within budgeted timelines and costs
Monitor the risk and control environment of the Technology and Cybersecurity operations including emerging risks by interacting with management and providing feedback through the Business Monitoring process
Assess impact of applicable regulations to the technology processes and adequacy of controls for compliance
Develop and maintain effective line management relationships for a no-surprises approach
Assess appropriateness and sustainability of pragmatic solutions for risk mitigation
Deliver the audit work assigned to a high quality in accordance with the requirements of the Quality Assurance scorecard/ IA methodology
Actively contribute to the automated auditing initiative for efficient and continuous control monitoring
Contribute to various corporate strategic initiatives by active participation and proactive stakeholder engagement

Fulltime

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Senior Quality Assurance Auditor

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