Back to job search

Manufacturing Quality Engineer – Deviations/Investigations

Massachusetts, USA

Overview

We are seeking a Manufacturing Quality Engineer to support ongoing production operations in a fast-paced manufacturing environment. This role is responsible for maintaining product quality after release to production, including managing nonconformances, supporting investigations, and partnering with manufacturing and QC teams to resolve issues on the shop floor.

This is a hands-on, production-facing quality role focused on sustaining quality and ensuring consistency across manufacturing processes.

 

Key Responsibilities

  • Investigate and resolve nonconformances (NCMRs), deviations, and production quality issues
  • Support customer complaint investigations and drive timely resolution
  • Maintain and update work instructions and quality documentation
  • Partner with Quality Control (QC) to troubleshoot inspection and measurement issues
  • Collaborate with manufacturing teams to ensure product is built and released in the correct condition
  • Support root cause analysis and implement corrective actions where needed
  • Contribute to continuous improvement of production quality processes

 

Required Qualifications

  • Experience as a Quality Engineer in a manufacturing environment
  • Hands-on experience supporting production floor activities
  • Strong background in:
  • Nonconformance management (NCMR)
  • Mfg. Quality Investigations
  • Root cause Analysis investigation
  • Production Quality Support
  • FMEA
  • Customer / Complaint Quality Investigations 
  • Ability to work cross-functionally with manufacturing, QC, and engineering teams

 

Preferred Qualifications

  • Experience in regulated industries (medical device strongly preferred)
  • Familiarity with GD&T and interpretation of complex engineering drawings
  • Experience supporting CMM inspection activities (programming not required)
  • Exposure or experience with Gage R&R (GR&R) (nice-to-have, not required)

 

What Makes a Strong Candidate

  • Experience working in fast-paced or startup manufacturing environments
  • Ability to balance regulatory compliance with practical problem-solving
  • Strong communication skills and ability to work through cross-functional challenges
  • Comfortable taking ownership of issues and driving them to resolution

 

Additional Notes

  • This role is focused on production/sustaining quality, not initial validation or NPI work
  • Candidates should be comfortable working onsite and directly on the manufacturing floor
  • Opportunity to extend or convert based on performance and business needs
Apply Now

Discipline

Job Ref

CR/030231

Published

20 days ago

Expiry

19 Jun 2026 23:59

Share job

LinkedInTwitterFacebookWhatsAppEmail

Submit your application

Other Related Jobs

Documentation Officer

New Malden, UK

We are currently recruiting a Documentation Officer to join a busy team based in New Malden. This role sits within a GMP‑regulated production environment and is ideal for someone with hands‑on experience handling documentation within manufacturing.

This position could also particularly suit an experienced Production Operative or Production Officer who has taken responsibility for GMP paperwork, batch records, or quality documentation as part of their role and is looking to move into a more documentation‑focused position.

 

Key Responsibilities

  • Preparing, reviewing, and maintaining GMP documentation
  • Completing and checking batch records, logs, and production paperwork
  • Ensuring documentation is accurate, compliant, and completed on time
  • Maintaining document control systems (paper‑based and/or electronic)
  • Supporting production and quality teams with documentation queries
  • Raising and correcting documentation errors in line with procedures
  • Ensuring compliance with GMP, SOPs, and data integrity standards

 

Skills & Experience Required

  • Previous experience working with GMP documentation
  • Background within an FMCG manufacturing environment (e.g. food, pharmaceutical, cosmetics, chemical, or similar)
  • Strong attention to detail and accuracy
  • Good understanding of SOPs, batch records, and controlled documents
  • Confident using basic IT systems (Word, Excel, document systems)
  • Organised, reliable, and comfortable working to deadlines
  • Able to work independently and as part of a team

 

What’s on Offer

  • Stable, Monday–Friday day hours (9am–5pm)
  • Clear transition pathway from production into a documentation‑led role
  • Supportive team environment
  • Training and ongoing development
  • Opportunity to work within a regulated, quality‑focused organisation

 

If you have GMP documentation experience from any FMCG manufacturing setting and are looking for a structured, office‑based role in New Malden, we would love to hear from you.

Production Operative

Wimbledon, London, UK

Multiple Vacancies | Immediate Starts Available

 Wimbledon (Applicants must be within a 45‑minute commute of Wimbledon)
Monday–Friday | 6:30am–3:00pm

We’re recruiting multiple Production Operatives to join a well‑established and growing manufacturing company in Wimbledon. With quick starts available, this is an excellent opportunity for experienced production staff looking for stable, weekday work in a clean, regulated environment.

If you’ve worked in manufacturing before - whether assembly, food, pharmaceutical, cosmetics, chemicals or similar - we want to hear from you.

 

The Role

You’ll be a key part of the production team, contributing to high‑quality manufacturing while following strict GMP standards.

Duties include:

  • Operating production line equipment in line with GMP requirements
  • Accurately following SOPs
  • Weighing, mixing, packing, or assembling products
  • Completing production and quality documentation
  • Maintaining a clean, safe, and organised work area
  • Adhering to all health & safety, hygiene, and quality procedures

 

What We’re Looking For

  • Previous experience in any manufacturing/ production/ assembly job
  • Experience using production or manufacturing equipment
  • Strong attention to hygiene, cleanliness, and quality standards
  • Ability to follow processes and work accurately
  • Reliable, punctual, and comfortable with early starts
  • Applicants must live within a 45‑minute commute of Wimbledon

 

What’s in It for You?

  • Immediate starts & multiple positions available
  • Consistent day shifts only (6:30am–3:00pm)
  • Monday to Friday – your weekends are yours
  • Supportive and friendly team environment
  • Full training and ongoing support
  • Stable, long‑term opportunities within a regulated facility

 

If you’re a Production Operative with some initial experience looking for a quick start, reliable hours, and a great work–life balance, apply today and secure your next role!

Lead Buyer

Cheshire, UK

Senior Lead Buyer – Healthcare Manufacturing

Are you ready to be part of a business driving real change?
Join a growing healthcare organisation with a rich heritage and a portfolio of specialist subsidiaries across pharmaceuticals and supplements. The business is entering a pivotal phase of transformation, focused on strengthening its procurement and supply chain capability to support continued growth.

About the Role
Buyer (Permanent)
Hybrid working (3 days onsite)
This is a high-impact, hands-on role where you’ll play a key part in stabilising and strengthening procurement operations during a period of organisational evolution.
You’ll be joining a function where structures are still developing, meaning success in this role will rely on your ability to:
•    Quickly assess situations
•    Make sound, pragmatic decisions
•    Operate with both strategic awareness and operational delivery
This role will suit someone with the gravitas to lead from the front, while remaining close to the detail and ensuring nothing slips through the cracks.

Key Responsibilities:
•    Manage procurement of raw materials and packaging components for pharmaceutical and supplement manufacturing
•    Conduct supplier evaluations and manage supplier relationships to ensure quality, compliance, and cost-effectiveness
•    Work cross-functionally with production, planning, and quality teams to meet customer requirements
•    Monitor and manage budgets, costs, and inventory levels to support operational efficiency
•    Support the Head of Procurement in strategic sourcing and continuous improvement initiatives
•    Play a hands-on role in ensuring continuity during the separation of procurement and supply chain responsibilities
•    Contribute to the onboarding, coaching, and development of team members
•    Ensure full compliance with MHRA and BRC standards
•    Engage directly with customers and suppliers to resolve issues and align expectations

What Makes This Role Different
•    A chance to step into a function that is evolving and requires shaping
•    Opportunity to have real operational impact in the short term
•    Work in an environment where leadership, adaptability, and hands-on delivery are equally valued
•    Exposure to complex supply chain challenges, including organisational restructuring

What We’re Looking For
•    Proven experience in a Buyer / Procurement role within pharma, food, FMCG, chemicals, or manufacturing
•    Ideally experience working in an SME or less-structured environment
•    Around 5+ years’ experience in buying/procurement
•    MCIPS Level 4 (or working towards) – or equivalent experience
•    Strong supplier management, negotiation, and evaluation skills
•    Confidence to work in an evolving structure and bring clarity quickly
•    Strong stakeholder engagement skills and the ability to build credibility across the business

Key Words:
Buyer, Procurement, Supply Chain, Purchasing, Supplier Management, Supplier Audits, MCIPS, Pharma, FMCG, Food, Manufacturing, Production, Healthcare, Packaging, Raw Materials, Compliance, MHRA, BRC

Quality Engineer

Boston, MA, USA

We've partnered with a rapidly growing medical device manufacturing organization looking to hire multiple Quality Engineering positions in support of a large scale-up initiative at an exciting time in their growth as they expand their manufacturing capabilities. These are pivotal roles focused on driving new revenue, opening new accounts, and building long-term client partnerships.

 

If you thrive in fast-paced production environments, enjoy solving manufacturing quality and validation challenges, and want to support a high-growth medical device organization during a critical scale-up phase, this opportunity is for you!

 

Quality Engineer Role Summary

You’ll be responsible for supporting manufacturing quality, validation, and production readiness activities as the organization expands its manufacturing capabilities.

  • Support day-to-day Manufacturing Quality Engineering activities on the production floor
  • Partner with Manufacturing, Quality, Engineering, Operations, and R&D teams to resolve production quality issues
  • Support manufacturing scale-up, production ramp, and new product/process introduction activities
  • Lead or support investigations related to NCRs/NCMRs, deviations, CAPA, root cause analysis, and corrective actions
  • Support process validation, equipment validation, inspection readiness, and documentation activities including IQ/OQ/PQ
  • Review and analyze quality data, inspection results, and manufacturing trends to identify issues and drive improvements
  • Support risk management activities including FMEA, process controls, and quality planning
  • Help ensure products, processes, and documentation meet internal quality, regulatory, and customer requirements

Quality Engineer profile

  • Quality Engineering experience within medical device, advanced manufacturing, or another regulated manufacturing environment
  • Experience with process validation, equipment validation, IQ/OQ/PQ, inspection methods, and validation documentation
  • Strong hands-on experience supporting production quality, manufacturing investigations, NCR/NCMR, CAPA, deviations, and root cause analysis
  • Comfortable working cross-functionally with Manufacturing, Engineering, Quality, Operations, and R&D teams in a fast-paced production environment

Preferred Experience

  • Medical device manufacturing quality experience
  • Knowledge of GD&T, Gage R&R, metrology, inspection strategy, FMEA, SPC, or process capability
  • Experience supporting manufacturing scale-up, production ramp, NPI, or new equipment/process implementation
  • Experience with automated manufacturing, advanced manufacturing, machining, or complex mechanical products

Why this role?

  • High-visibility role supporting a major manufacturing expansion initiative
  • Opportunity to make a direct impact on production readiness, quality systems, and manufacturing performance
  • Hands-on role with strong cross-functional exposure across Manufacturing, Engineering, Quality, and Operations
  • Long-term growth potential with a rapidly scaling medical device manufacturing organization

Ideal for a hands-on Quality Engineer who enjoys solving production quality challenges, supporting validation and manufacturing readiness, and playing a key role in a fast-paced scale-up environment.

Senior Manager, Pharmacovigilance

California, USA

Partnering with a clinical-stage biotech building in oncology as they look for a Senior Manager, Pharmacovigilance to take ownership of end-to-end PV activities across global clinical programs. This is an opportunity to blend hands-on execution with strategic oversight.

You’d be stepping into a highly visible role, working cross-functionally to drive safety strategy, oversee vendors, and support regulatory deliverables across development.

This role is onsite, based in San Diego and ideal for someone who enjoys being close to the science and the team.

What you’ll bring:

• 8+ years in pharmacovigilance (biotech/pharma experience required)

• Strong knowledge of global PV regulations (FDA, EMA, ICH)

• Experience in safety surveillance, signal detection, and aggregate reporting

• Background in oncology (additional autoimmune a plus)

• Proven vendor oversight + cross-functional collaboration

Senior Manager, PV

USA

A clinical-stage biotech partner doing exciting work in immunology is hiring a Senior Manager, PV to join their growing safety team.

 

This is a high-impact role owning PV activities across clinical programs, with a strong emphasis on signal detection, reporting (PSURs, DSURs) and cross-functional collaboration.

What you’ll bring:

• 8+ years in pharmacovigilance within biotech/pharma

• RN background + PharmD (required)

• Hands-on experience in case processing, medical review, and safety surveillance

• Strong understanding of global PV regulations (FDA, EMA, ICH)

• Experience with signal detection and aggregate reporting

• Comfortable working cross-functionally in a fast-paced environment