Supplier Quality Excellence Specialist Job at Nordex Group (Chennai)

Sr. Quality Specialist, Supplier Quality

Carex is partnering with a Pharmaceuticals industry partner to identify a Suppli...

Location

United States , Madison

Salary:

Not provided

Carex Consulting Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific field
Minimum of 8 years of experience in pharmaceutical or biotechnology quality, including at least 4 years in supplier quality
Strong knowledge of FDA, EMA, ICH, GxP, and GDP regulations
Experience managing supplier quality systems, including SCARs and change notifications
Excellent communication skills with the ability to collaborate across diverse teams and external partners
Strong attention to detail, organizational skills, and a proactive problem-solving mindset
Experience with electronic document management systems in regulated environments preferred
Proficiency with Adobe Acrobat, Microsoft Office, DocuSign, and SmartSheet preferred
Ability to work independently, manage priorities, and operate effectively in a fast-paced environment
Strong interpersonal, verbal, and written communication skills with a professional approach to external interactions

Job Responsibility

Manage Supplier Corrective Action Requests (SCARs) and Supplier Change Notifications (SCNs), ensuring timely assessment, resolution, and effectiveness
Guide and coach stakeholders on SCAR and SCN processes to promote consistency and strengthen quality culture
Support cross-functional evaluation of supplier changes and corrective actions, including impact assessments and follow-up activities
Oversee quality agreement lifecycle management, including drafting, reviewing, approving, and maintaining compliance with periodic reviews
Assist in establishing and tracking Supplier KPIs and contribute to Quality Management Reviews and Business Review meetings
Maintain current knowledge of regulatory requirements and compliance expectations related to drug development
Author, review, and maintain procedural documentation such as SOPs, work instructions, policies, and forms
Support regulatory inspections as a subject matter expert
Ensure compliance with cGMP, 21 CFR, USP, EP, and ICH standards
Perform additional responsibilities aligned with the role as needed

Fulltime

New

Supplier Quality Specialist (Electronics)

Hunter Douglas is the world's leading manufacturer of window coverings and a maj...

Location

Mexico , Rosarito

Salary:

Not provided

Hunter Douglas

Expiration Date

Until further notice

Requirements

Bachelor's degree in Electronics Engineering or related field
7+ years of experience in Supplier Quality, Manufacturing Quality, or Electronics Engineering
Strong experience with electronic components (PCBA, IPC Standards, semiconductors, etc.)
Proven track record in resolving complex, chronic electronic supplier quality issues
Hands-on experience managing and approving PPAPs
Deep knowledge of quality tools: PFMEA, Control Plans, MSA, SPC, 8D
Familiarity with IPC standards (e.g., IPC-A-610, IPC-J-STD-001)
Understanding of electronics manufacturing processes (SMT, wave soldering, testing)
Excellent communication and stakeholder management skills
Ability to influence suppliers and internal teams without direct authority

Job Responsibility

Act as the technical authority on electronic components, including PCBs, PCBAs, transmissions, and motors
Provide guidance on industry standards (IPC and applicable regulatory standards)
Support design reviews (DFMEA, PFMEA) to ensure quality is built into the product and process
Advise internal teams and suppliers on best practices in electronics manufacturing and quality assurance
Utilize structured problem-solving methodologies, 8D/DMAIC, A3, etc., to lead root cause analysis and corrective actions for chronic and high-impact supplier quality issues
Drive permanent corrective actions and validate their effectiveness
Analyze supplier performance data to identify trends and proactively mitigate risks
Escalate critical issues and lead cross-functional containment and recovery plans
Lead and coordinate the PPAP process for electronic components and assemblies, ensuring all PPAP elements (PSW, control plans, MSA, capability studies, etc.) meet requirements
Review and approve supplier documentation for completeness and compliance

What we offer

Annual base salary
Annual bonus
Generous benefits package including medical, dental, vision, life
A company culture that prioritizes internal development and professional growth
Time off with pay (3 days annual)
Christmas bonus
Savings fund

Fulltime

Specialist I, Supplier Quality

This position supports Supplier Quality Assurance with activities related to sup...

Location

United States , Pasadena; San Diego

Salary:

68000.00 - 80000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

Associate’s degree, with BS/BA preferred
1+ year of quality assurance experience
Ability to follow company procedures, work instructions, and policies
Competent knowledge of and ability to use Microsoft Word, Outlook, PowerPoint and Excel
Excellent attention to detail and organizational skills
Ability to multi-task and prioritize work with minimal supervision
Excellent interpersonal, verbal, and written communication skills

Job Responsibility

Manage initial intake of new regulated suppliers from the business teams
Conduct or assist with supplier risk assessments
Coordinate with internal and external auditors performing supplier audits
Maintain supplier, audit, and qualification records within Veeva
Support Lead Auditors by tracking timelines and preparing required documentation
Maintain supplier licenses, certifications, and related compliance documentation within Veeva
Generate and distribute supplier metrics to QA groups and business stakeholders
Support Arrowhead audits and inspections
Assist with preparation, update, review, and routing of Arrowhead procedural documents
Support eQMS and other system implementations

What we offer

competitive salaries and an excellent benefit package

Fulltime

Audit Quality Specialist

Membership Bespoke is delighted to be supporting a globally recognised membershi...

Location

United Kingdom , Ashford

Salary:

55000.00 GBP / Year

Membership Bespoke

Expiration Date

Until further notice

Requirements

Recognised Internal Auditor qualification
Recognised Lead Auditor qualification
Experience working within quality assurance, certification, accreditation, compliance or audit environments
Strong knowledge of audit methodologies and quality management systems
Excellent communication and stakeholder management skills
Experience of ISO-based standards and audit frameworks
Experience in external, certification, accreditation or supplier auditing
Audit quality assurance and report review
Managing, mentoring or developing auditors
Auditor calibration and competence assessment

Job Responsibility

Drive consistency, quality and continual improvement across the audit programme
Review audit reports and provide constructive feedback to auditors
Monitor auditor performance and identify opportunities for development and improvement
Support auditor calibration and promote consistent interpretation of standards and audit findings
Conduct internal audits and support risk-based audit planning activities
Analyse audit data and trends to identify risks, opportunities and areas for improvement
Produce management reports and quality metrics
Develop and enhance audit procedures, guidance and best practice documentation
Support auditor recruitment, onboarding and ongoing competence development
Ensure compliance with relevant quality, governance and certification standards

What we offer

Free parking

Fulltime

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Management Consultancy experience highly desirable
A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
Typically 8+ years experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
Hands-on experience with supplier qualification, audits, CAPA and compliance management
Experience of RIM and PLM system implementation in regulated environments (highly desirable)
Knowledge of computer system validation and data integrity principles
Excellent problem-solving, communication and stakeholder management skills
QP status is highly desirable but not essential

Job Responsibility

QMS design and process transformation
Leading the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10)
Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence
Supporting effective change management, embedding best practices through close collaboration with quality, technical and business teams
Computer system validation and data integrity
Leading and advising on computer system validation (CSV) activities within GxP environments
Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations
Supplier quality and audit support
Applying hands-on experience in supplier qualification, evaluation and audit activities (internal and external)

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Management Consultancy experience highly desirable
A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
Hands‑on experience with supplier qualification, audits, CAPA and compliance management
Experience of RIM and PLM system implementation in regulated environments (highly desirable)
Knowledge of computer system validation and data integrity principles
Excellent problem‑solving, communication and stakeholder management skills

Job Responsibility

QMS design and process transformation
Computer system validation and data integrity
Supplier quality and audit support
Regulatory systems implementation
Regulatory and Qualified Person (QP) support
Client and stakeholder engagement

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

Quality Specialist

We are looking for a dedicated Quality Specialist to join our team in Santa Barb...

Location

United States , Santa Barbara

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Lead investigations into discrepancies, identifying root causes and ensuring timely resolution and documentation
Support quality initiatives by developing and improving administrative processes and driving continuous improvement efforts
Collaborate with teams to identify and address inefficiencies within internal workflows
Manage and enhance the electronic Quality Management System, including designing workflows and providing staff training
Develop and implement effective training programs, including creating training materials and evaluating their success
Oversee and expand the supplier approval program, ensuring compliance and quality standards are met
Design and monitor product quality initiatives as part of supplier quality management
Conduct supplier audits, including site visits for third-party logistics providers
Partner with cross-functional teams to promote adherence to industry regulations and best practices
Proficiency in Microsoft Office tools, including Word, Excel, Visio, PowerPoint, and SharePoint

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Combination Product Quality Specialist Consultant

We are seeking an experienced Combination Product Quality Specialist to support ...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

Requirements

Prior management consultancy experience is highly desirable
A degree in life sciences, pharmacy, engineering, or a related discipline
Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
Proven experience authoring and maintaining quality and technical documentation in regulated environments
A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
Experience with supplier quality, audits, CAPA and document control
Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

Job Responsibility

Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records
Supporting supplier qualification, audits and gap assessments
Acting as a subject matter expert on drug–device interactions and product integrity considerations
Interpreting and overseeing Container Closure Integrity Testing (CCIT)
Supporting the design and evaluation of stability and compatibility studies
Interpreting and applying evolving global combination product regulations
Supporting the preparation of regulatory submissions, technical dossiers and responses
Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
Contributing to process validation, equipment qualification and technical knowledge transfer

What we offer

Health and lifestyle perks accompanying private healthcare
25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
Generous company pension scheme
Opportunity to get involved with community and charity-based initiatives
Annual performance-based bonus
PA share ownership
Tax efficient benefits (cycle to work, give as you earn)

Fulltime

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Supplier Quality Excellence Specialist

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