Quality Systems & Manufacturing Engineer
Global Surgical Corporation · St. Louis, MO
- Level
- Engineer
- Team
- Quality
- Degree
- Required (or equivalent experience)
- Experience asked
- 5+ years
- Industry
- Industrial
- Posted
- 23 days ago
The role in 30 seconds
An engineer-level quality role at Global Surgical Corporation (industrial) in St. Louis, MO.
- They ask for
- 5+ years · degree required (or equivalent experience)
- Tools it names
- Six Sigma, Root cause, FMEA, CAPA, ISO 13485, FDA / GMP
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in Missouri: typical posted base $100k–$141k.
Median of the low and high ends of 6 live postings that list pay, out of 19 quality engineer openings in Missouri, read from manufacturers' own careers sites.
Missouri plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 18 other live quality postings in Missouri.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $100k–$141k, from 6 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Six Sigma 63%
- ✓ Root cause 58%
- ✓ Validation (IQ/OQ/PQ) 47%
- ✓ CAPA 42%
- Lean 42%
- ISO 9001 32%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Global Surgical Corporation
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
Full description from Global Surgical CorporationAs posted on their careers site.ShowHide
About the Role
Global Surgical Corporation is seeking a hands-on Quality Systems & Manufacturing Engineer to lead our Quality Management System (QMS), support regulatory compliance activities, and drive quality improvements within manufacturing operations.
This role combines quality systems leadership, manufacturing quality engineering, and routine regulatory compliance responsibilities. The successful candidate will work closely with Engineering, Manufacturing, Quality, Technical Service, suppliers, and executive leadership to ensure products and processes consistently meet customer, company, and regulatory requirements.
This is an ideal opportunity for an individual who enjoys improving systems, solving manufacturing problems, leading investigations, and building practical processes within a regulated manufacturing environment.
Essential
requirements
and performance metrics.
- ✓Participate in supplier audits and supplier improvement initiatives.
Required
- ✓Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical field, or equivalent experience.
- ✓5+ years of experience in Quality Engineering, Quality Systems, Manufacturing Engineering, or a related role within a regulated manufacturing environment.
- ✓Experience with:
- ✓CAPA
- ✓Complaint Handling
- ✓Change Control
- ✓Internal Audits
- ✓Supplier Quality
- ✓Nonconforming Product
- ✓Document Control
- ✓Quality System Administration
- ✓Experience conducting root cause investigations and implementing corrective actions.
- ✓Ability to read and interpret technical drawings, specifications, and manufacturing documentation.
- ✓Strong communication, organizational, and project-management skills.
- ✓Ability to work independently and manage multiple priorities.
requirements
are not met.
What Success Looks Like
Successful performance in this role includes
- ◆Timely closure of complaints, CAPAs, and nonconformance investigations.
- ◆Improved QMS effectiveness and employee adoption of procedures.
- ◆Reduced manufacturing defects, scrap, rework, and recurring quality issues.
- ◆On-time comp
Show full description ↓Show less ↑
Description
Quality Management Systems
- •Serve as the primary operational owner of the company Quality Management System.
- •Maintain and improve QMS processes including:
- •Document Control
- •Training
- •Change Control
- •CAPA
- •Complaint Handling
- •Internal Audits
- •Supplier Qualification
- •Management Review
- •Risk Management
- •Process Validation
- •Revise and simplify procedures, work instructions, forms, and workflows to improve effectiveness while maintaining compliance.
- •Coordinate employee training on new and revised quality processes.
- •Monitor quality metrics and report trends, risks, and improvement opportunities to management.
- •Support audit readiness and continuous improvement initiatives.
Complaint Handling & CAPA
- •Administer complaint handling and investigation processes.
- •Review complaints, determine investigation requirements, and coordinate cross-functional investigations.
- •Lead corrective and preventive action activities.
- •Analyze complaint, service, warranty, and quality records for recurring trends.
- •Manage nonconforming product and corrective action activities.
- •Ensure quality records are complete, accurate, and inspection ready.
Manufacturing Quality Engineering
- •Provide hands-on support to manufacturing operations.
- •Lead root cause investigations for quality and production issues.
- •Improve manufacturing processes, inspection methods, and quality controls.
- •Analyze quality data to identify opportunities for scrap reduction, improved yield, and process improvements.
- •Support process validation activities and manufacturing change implementation.
- •Assist in developing work instructions, inspection procedures, and quality plans.
- •Partner with manufacturing teams to improve product quality and operational efficiency.
Supplier Quality
- •Support supplier qualification and monitoring activities.
- •Investigate supplier-related quality issues.
- •Lead supplier corrective action requests when necessary.
- •Establish and maintain supplier quality
Change Control & Product Support
- •Review engineering and manufacturing changes for quality and regulatory impact.
- •Support Engineering Change Order (ECO) implementation.
- •Ensure documentation, training, validation, and approvals are completed prior to implementation.
- •Support product releases and manufacturing transfers.
- •Participate in risk assessments and product improvement activities.
Regulatory Compliance
- •Maintain regulatory records, registrations, and UDI/GUDID information.
- •Support FDA, Canada, EU, UK, and other applicable regulatory requirements.
- •Assist with distributor requests, product registrations, declarations, and compliance documentation.
- •Evaluate routine regulatory impact of product, supplier, process, and labeling changes.
- •Support complaint evaluations for potential regulatory reporting requirements.
- •Coordinate activities with external testing laboratories, certification bodies, and regulatory consultants as needed.
Preferred
- +Medical device manufacturing experience.
- +Knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485.
- +Experience with UDI/GUDID and international product registrations.
- +Familiarity with ISO 14971 risk management principles.
- +Experience with process validation and FMEA activities.
- +Supplier audit experience.
- +ASQ CQE, CQA, Six Sigma, or related certifications.
- +Experience with ERP, eQMS, CAPA, or document-control systems.
Authority & Decision Making
This position is authorized to
- •Place nonconforming material on hold.
- •Require investigations and corrective actions.
- •Initiate CAPAs.
- •Reject incomplete change requests.
- •Escalate quality, compliance, or product-safety concerns.
- •Approve assigned quality-system documents and records.
- •Recommend product release holds when