CrawlJobs Logo

Specialist - Quality Excellence

India, Chennai · Job Posted March 19, 2026
Apply Position
Job Link Share

Job Description

We are seeking a highly skilled and dynamic Quality Control & FMEA Specialist with strong project management expertise. In this role, you will lead end-to-end quality planning activities, ensure alignment between FMEAs and control plans, and drive cross-functional improvements across global teams. You will work closely with diverse stakeholders to uphold customer requirements, enhance quality standards, and foster a culture of continuous improvement.

Job Responsibility

  • Verify that end-to-end control plans (including SPCs) are fully aligned with P‑FMEAs and D‑FMEAs
  • Ensure all critical and special characteristics are accurately derived from FMEAs and translated into robust control plans
  • Lead ongoing improvements to baseline quality standards and best practices (MSA, Lean, Kaizen, APQP frameworks)
  • Identify improvement opportunities and implement preventive quality measures across processes
  • Own and manage lessons learned documentation in alignment with FMEAs and control plan updates
  • Ensure consistent application of updated standards across teams and projects
  • Coordinate with internal and external stakeholders to ensure alignment on project timelines, cost expectations, and customer requirements
  • Facilitate smooth collaboration with global teams and ensure successful project deliverables

Requirements

  • Bachelor’s degree (minimum) or Master’s degree in Mechanical or Electrical Engineering
  • Minimum 3 years of project management experience, preferably in multi-national environments
  • Minimum 2 years of experience developing quality control plans derived from P‑/D‑FMEAs
  • Knowledge and hands-on experience in APQP, Six Sigma, FMEA methodologies, SPCs, and quality tools (certifications preferred)
  • At least 3 years of experience working with global teams, demonstrating adaptability and strong organizational skills
  • Strong understanding of supply chain quality processes and control plan requirements
  • Excellent communication skills in English (mandatory)
  • German or Spanish is an added advantage
  • Creative, structured, humorous, and persuasive—able to communicate and collaborate effectively with cross-functional teams

Nice to have

German or Spanish is an added advantage

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Specialist - Quality Excellence

8 matching positions

Supplier Quality Excellence Specialist

Location
Location
India , Chennai
Salary
Salary:
Not provided
nordex-online.com Logo
Nordex Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in business or engineering
  • 5+ years in supplier Quality or Quality engineering experience in implementing quality improvement programs
  • Knowledge of structured data analysis, statistics and data techniques for supplier performance analysis and reporting
  • Ability to supervise projects and direct cross-functional teams
  • Good level of understanding on Supplier Quality development process, supply chain Performance Management
  • Experience in advanced reporting, dashboards and other solutions using tools like Power BI, Advance Excel, SQL, Excel, SharePoint
  • Team-oriented professional with strong independent judgment and proactive approach in change management
  • Highly motivated, action-oriented, and committed to achieving tasks and targets with a problem-solving mindset
  • Skilled communicator, capable of working effectively with stakeholders at all business levels
  • Proficient in delivering engaging and clear presentations to diverse audiences
Job Responsibility
Job Responsibility
  • Monitor, improve, and develop suppliers through performance monitoring to support Supplier Quality Development activities
  • Designing, implementing, and maintaining systems to audit, evaluate, and monitor supplier performance
  • Establishment of supplier performance analysis and reporting like Supplier score card, KPI reporting, Risk Management and data management
  • Contribute to data-based continuous quality improvement
  • Collaborate with global team, Stakeholders to identify continuous improvement opportunities to further develop and deploy SQA processes, approaches
  • Escalation of critical supplier QHSE performance issues to drive Supplier quality improvement projects (SQIPs) by SQA owners
  • Facilitate and follow up on escalated corrective actions and lessons learned transferred to SQA process improvements
  • Strengthen relationships with suppliers and internal stakeholders (Sourcing, SQA, HSE, Engineering, Manufacturing Sustainability etc.) to promote collaboration and clarity
  • Support the onboarding process for new suppliers and train them on new processes, tools, and products to ensure compliance with company standards
Read More
Arrow Right

Process Quality Excellence Specialist

This is a hands-on, coordination-focused quality role, suited to someone comfort...
Location
Location
United Kingdom , Berkshire
Salary
Salary:
47.92 GBP / Hour
ckgroup.co.uk Logo
CK Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
  • Prior involvement in quality audits, either as an audit host or audit support function
  • Strong understanding of GCP and clinical research regulatory requirements
  • Excellent organisational, coordination, and communication skills
  • Ability to work across multiple stakeholders and manage timelines effectively
  • QA background welcomed but not essential
Job Responsibility
Job Responsibility
  • Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
  • Review new and updated regulations and guidance, assessing impact on controlled documents
  • Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
  • Track actions and timelines, ensuring follow-up and completion
  • Act as a point of contact to confirm CRO assessment of regulatory and country-specific requirements impacting SOPs and clinical studies
  • Act as Audit Host for internal quality audits
  • Coordinate with the internal Auditing team and relevant SMEs and functions
  • Prepare for audits, manage documentation requests, and track timelines
  • Support SMEs during audits by coordinating responses to auditor queries
  • Manage post-audit activities including findings, CAPAs, and follow-up actions through to audit closure
  • Fulltime
Read More
Arrow Right

Sr. Quality Specialist, Supplier Quality

Carex is partnering with a Pharmaceuticals industry partner to identify a Suppli...
Location
Location
United States , Madison
Salary
Salary:
Not provided
carexconsulting.com Logo
Carex Consulting Group
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Clinical Specialist, Quality Management I

Who We Are: Because health is personal. That's why Personify Health created the ...
Location
Location
United States
Salary
Salary:
60600.00 - 91000.00 USD / Year
personifyhealth.com Logo
Personify Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Active, unrestricted Registered Nurse (RN) license required
  • Basic computer literacy
  • The ability to work on multiple screens, and proficient typing skills
  • Proficiency in software applications including, but not limited to, Microsoft Word, Microsoft Excel, and Outlook
  • Ability to speak clearly and convey complex or technical information in a manner that others can understand, as well as ability to understand and interpret complex information from others
  • Ability to work independently and utilize written resources to problem solve
  • After training with our training department and 1.5 months ramp (3 months total), must have and be able to work in: Teams on and off camera, SharePoint, Drives as needed, VPN, UM Web or Health Notes, El Dorado, Quick Links, GIAS, ADP, Confluence, Phone system with headset, Smartsheet
  • Knowledge of medical claims and ICD-10, CPT, HCPCS coding
  • Excellent verbal and written communication skills for upward and downward conversations
  • Level I: In-depth knowledge of applicable regulations and accreditation standards (HIPAA, CMS requirements as applicable, NCQA, URAC)
Job Responsibility
Job Responsibility
  • Ensure compliance with state, federal, and accreditation requirements (e.g., HIPAA, CMS, NCQA, URAC, ERISA, as applicable)
  • Conduct internal and external audits of UM/CM/CDM processes and documentation
  • prepare audit files, findings, and corrective action recommendations
  • Identify quality and compliance risks and collaborate with cross-functional partners on mitigation and resolution
  • Review and support SOPs and workflows to ensure regulatory alignment and operational clarity
  • Support external audit readiness activities, including NCQA and URAC evidence preparation and maintenance
  • Develop, maintain, and deliver role-based training curriculum aligned to compliance standards, quality goals, and operational workflows
  • Conduct onboarding and orientation to prepare staff for assigned UM/CM/CDM functions
  • Deliver training using multiple modalities (virtual, self-paced, and one-on-one coaching) tailored to adult learners
  • Ensure training covers applicable processes such as case initiation and closure, documentation standards, high-dollar case monitoring, stop-loss notification, administrative support, customer service, and productivity expectations
What we offer
What we offer
  • Competitive base salary and benefits effective day one
  • Comprehensive medical and dental through our own health solutions (yes, we use what we build)
  • Unlimited PTO—rest and recharge time is non-negotiable
  • Mental health support, retirement planning, and financial protection
  • Professional development with clear career progression and learning budgets
  • Mission-driven culture where diverse perspectives drive real impact on people's health
  • Fulltime
Read More
Arrow Right

Specialist, Quality Complaint Investigation

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Malta , San Ġwann tal-Għargħar, San Ġwann
Salary
Salary:
27200.00 EUR / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Medical Device Experience with knowledge of 21CFR820 preferred
  • Investigational research skills
  • Experience with any statistical software packages (Minitab a plus)
  • Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
  • Knowledge and working application of FDA cGMP
  • ANSI/ISO/ASQC requirements
  • CMDAS (optional)
  • Knowledge and working application of reading and understanding blueprints and technical drawings
  • Demonstrated strong analytical problem solving (Root Cause Investigations
  • Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools)
Job Responsibility
Job Responsibility
  • Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs
  • Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint
  • Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues
  • Prepare and issue reports based on information analysis
  • Review existing investigation reports and identify gaps for GMP compliance
  • Develop strategies and plans to close the gaps in an efficient and technical manner
  • Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions
  • Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation
  • Support CAPA and maintenance activities for existing product lines
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • competitive benefits
  • discretionary bonuses
  • long-term incentive
  • Fulltime
Read More
Arrow Right

Audit Quality Specialist

Membership Bespoke is delighted to be supporting a globally recognised membershi...
Location
Location
United Kingdom , Ashford
Salary
Salary:
55000.00 GBP / Year
membershipbespoke.co.uk Logo
Membership Bespoke
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Free parking
  • Fulltime
Read More
Arrow Right

Operations Excellence Specialist

Join our internal Operations team at Staffinc and seize the opportunity to contr...
Location
Location
Indonesia , South Jakarta
Salary
Salary:
Not provided
Staffinc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree, preferably in Industrial Engineering, Management, related fields
  • 2 - 4 years of experience in operations, governance, audit, ISO, quality management, or process improvement
  • Experience in handle ISO related Process
  • Certification (advantage): ISO 9001 Lead Auditor, ISO 27001 ISMS, Lean Six Sigma, or other related certifications
  • Strong understanding of ISO standards (9001, 27001) and audit practices
  • Proficient in drafting and managing documents (SOPs, policies, audit reports)
  • Analytical and problem-solving skills to identify process gaps and solutions
  • Detail-oriented, systematic, and accurate
  • Strong collaboration skills to work across teams
  • Proficiency in English for documentation and communication
Job Responsibility
Job Responsibility
  • Develop, maintain, and update operational documents (SOPs, policies, work instructions)
  • Ensure operational processes comply with both internal standards and external standards (e.g., ISO 9001, ISO 27001)
  • Support internal and external audit activities, including follow-up on audit findings (Corrective & Preventive Actions)
  • Deliver training, awareness, and communication on policies and standards
  • Monitor compliance of BUs with company policies and procedures
  • Identify gaps or risks within operational processes
  • Provide recommendations to improve process quality and compliance
  • Participate in cross-BU improvement projects (process optimization, cost efficiency, digitalization)
  • Support the development, monitoring, and evaluation of operational KPIs
  • Assist with benchmarking best practices across BUs
  • Fulltime
Read More
Arrow Right

Senior Quality Specialist

The main purpose of the job is to confirm proper satisfaction and documentation ...
Location
Location
United States , Solon
Salary
Salary:
Not provided
purina.com Logo
Nestlé Purina
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree
  • 5+ years of inventory experience and/or food safety management experience
  • Base auditing proficiency established
  • Strong analytical skills with attention to details
  • Well-organized, methodical thinker
  • Self-Motivator who can drive for resolution of problems
  • Strong and creative problem-solving skills
  • Able to prioritize and juggle multiple demands
  • Manages time well
  • Works well in high-pressure environment
Job Responsibility
Job Responsibility
  • Confirm proper satisfaction and documentation of quality release criteria for all assigned materials as specified by the Quality Expert
  • Un-restrict all batches which fully comply with release criteria in timely manner
  • Maintain records to support the decision for each batch that is released or moved to blocked status
  • Resolve discrepancies in documentation of release requirements and batch information, including bad batch receipts at DC’s and warehouses
  • Support logistics and deployment staff by researching and/or resolving issues with material release to support timely shipment
  • Run availability report to ensure the good receipt processing time is followed by CoMan
  • Maintain accurate records of release requirements for each location
  • Maintain files and records to be easily understood and accessed in the event of a product issue
  • Accurately resolve inventory synchronization issues related to release and/or block status of materials assigned
  • Create batches per logistics staff to clear IDOC failures and maintain proper documentation for proof of batch creation
  • Fulltime
Read More
Arrow Right