Trelleborg AB

NPD Quality Engineer

Trelleborg AB • $78K — $97K *
Delano, MN 55328In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 4-year degree in quality, engineering or related field
  • 2+ years in a manufacturing technical support role
  • ASQ Certified Quality Engineer (preferred)
  • Formal Six Sigma Yellow/Green belt training (preferred)
  • Knowledge of GMP/ISO standards including ISO 9000/9001, ISO 13485, and FDA regulations (preferred)

Responsibilities

  • Adhere to TMS Quality Management System and its requirements
  • Collaborate with NPD team on validation strategies for equipment, software, and processes
  • Monitor project deliverables, ensuring timely completion and addressing issues promptly
  • Conduct risk management using tools like pFMEA
  • Authenticate protocols and reports for Equipment Qualification and Validation
  • Plan and oversee Test Method Development activities
  • Collaborate with Metrology team on measurement techniques and sampling plans

Benefits

  • Generous benefits package including health, dental, and vision coverage
  • 401k plan with company match
  • Paid time off and tuition reimbursement options
  • Clean, climate-controlled work environment
  • Opportunities for advancement in a global company
Full Job Description
The NPD Quality Engineer is responsible to plan and coordinate quality engineering activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with other New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.

As a valued team member with Trelleborg, you will enjoy:
  • Competitive compensation: $78,000 - $97,000 Annual Salary
  • Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
  • Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
  • Greater opportunity for impact: You will have the autonomy and support to lead the production team and impact the production of life-saving devices.
  • Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Qualifications:

Required
  • 4-year degree in quality, engineering or any related field
  • 2+ years in a manufacturing environment in a technical support role

Desired:
  • ASQ Certified Quality Engineer
  • Formal Six Sigma Yellow/ Green belt training
  • Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR.

Responsibilities:
  • Knowledgeable and adheres to TMS Quality Management System and its requirements.
  • Works with the NPD team to plan, develop and execute equipment, software, test method, and/or process validation strategy
  • Monitors and reports out on project deliverables to ensure timely completion; escalates issues, questions, and concerns, immediately to prevent project delays.
  • Performs risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)
  • Authors or approves protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ). • Reviews and evaluates specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
  • Plans, coordinates, and oversees Test Method Development activities; initiates inspection plans for new/revised product.
  • Works with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
  • Performs measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
  • Performs statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
  • Authors and executes Quality Plans, when needed • Support resolution of deviations and nonconforming issues arising during development; completes investigations and perform root cause analysis.
  • Reviews and ensures compliance with QMS of all validation documents and records
  • Supports Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
  • Communicates with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects, as needed.
  • Understands regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR)
  • Provides periodic work direction and assistance to QA inspectors and QE Technicians
  • Supports other quality activities such as customer complaints, MRBs, and CAPAs
  • Drives best practices through the application of effective quality engineering principles and procedures across functions.
  • Supports internal and external audits.
  • Other duties as assigned.


About Trelleborg AB

Trelleborg AB is a global engineering group focused on polymer technology, with headquarters in Trelleborg, Sweden. The company operates in three main business areas: Trelleborg Industrial Solutions, Trelleborg Sealing Solutions, and Trelleborg Wheel Systems. Trelleborg's products are used in a wide range of industries, including aerospace, automotive, construction, healthcare, and oil and gas. The company has operations in over 50 countries and employs approximately 24,000 people. Trelleborg is listed on the Stockholm Stock Exchange and has a market capitalization of approximately SEK 50 billion.
Learn more about Trelleborg AB
Size
24,000 employees
Industry
Manufacturing & Automotive
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Trelleborg AB

  • Trelleborg AB
    NPD Quality Engineer
    $78K — $97K *
    Delano, MN 55328 (Wright County)
    Today
    Pharmaceuticals & Biotech
    In-Person
  • Trelleborg AB
    Aerospace Application Engineer II
    $90K — $130K *
    Northborough, MA 01532 (Worcester County)
    Yesterday
    Aerospace & Defense
    In-Person
  • Trelleborg AB
    Planning Manager
    $100K — $120K *
    Warrendale, PA 15086 (Allegheny County)
    2 days ago
    Aerospace & Defense
    In-Person
  • Trelleborg AB
    Integration Analyst
    $100K — $130K *
    Northborough, MA 01532 (Worcester County)
    3 days ago
    Information Technology
    In-Person
  • Trelleborg AB
    Design Engineer
    $80K — $100K *
    Northborough, MA 01532 (Worcester County)
    3 days ago
    Manufacturing & Automotive
    In-Person

More Pharmaceuticals & Biotech Jobs

Find similar NPD Quality Engineer jobs:

NationwideDelano, MN