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Quality Engineer

Nelipak · Phoenix, AZtoday
$70k – $90kfrom the posting

BS-level Quality / Testing roles on Crosslinked list a median of $111k (200 that show pay).

Own quality engineering for medical packaging manufacturing: process validation, CAPA, nonconformance disposition and sampling plans under ISO 13485.

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Worth knowing

Why it is interesting. Quality ownership for medical packaging with validation (IQ/OQ/PQ) and customer-facing responsibility in an ISO 13485 setting

Might not be for you. Compliance-heavy QE work with little materials R&D; 5-7 years required

Deep specialist Senior hires only

Adjacent materials roleThermoforming and/or medical packaging experience a plus; BS in mechanical, materials, biomedical engineering; process/test method validation at a medical packaging maker

Seniority
Mid-level
Work
On-site
Type
Full-time
Degree
BS
Experience
5–7 yrs
Industry
Medical devices
Role
Quality / Testing
Techniques
process validation (IQ/OQ/PQ)2 rolestest method validation6 rolesDOE270 rolesSPC293 roles

Role details

JOB DESCRIPTIONS DETAIL NELIPAK

Function: QAQE - QUALITY ASSURANCE Job: QUALITY ENGINEER

Job Description: Quality Engineer

Collaborates with customer and Nelipak engineering and product teams to establish material, process, and product quality standards, specifications, and manufacturing methods. Applies sound Quality Engineering principles to help ensure customer requirements are consistently met while maintaining compliance to ISO 13485 and other applicable Standards, Regulations, and Nelipak policies

Essential job duties and responsibilities include the following:

  • Assist in the development and deployment of manufacturing processes, and changes to such processes.
  • Prepare and oversee the execution of validation studies, including DOEs, IQs, OQs, PQs, and Test Method Validations.
  • Develop, validate, and deploy sampling plans and test methods.
  • Assist in the development and maintenance of Design and Process FMEAs.
  • Oversee the evaluation and disposition of nonconforming materials and product.
  • Lead the evaluation and resolution of quality-related product and production problems via the CAPA process.
  • Spearhead recommendations for reducing actual or potential quality costs, especially costs of poor quality.
  • Provide guidance to Quality Technicians, Supervisors, and Inspectors.
  • Interfaces with customer representatives regarding quality issues and opportunities for improvement.
  • Read and interpret engineering drawings and technical specifications.
  • 1st article process that includes measurement, analyzing and report data.

Education and/or Experience:

  • 5-7 years of quality engineering experience in a manufacturing environment, including design transfer, validation, and measurement analysis.
  • BS in mechanical, materials, biomedical, or similar engineering.
  • Quality Engineer (CQE) and/or Six Sigma Green/Black Belt certification(s) strongly preferred.
  • Experience operating in ISO 9001, AS 9001, and/or ISO 13485 environments strongly preferred.
  • Familiarity with ISO 14971 a plus.
  • Thermoforming and/or medical packaging experience a plus.

Skills and Abilities:

  • Proficient in MS Office, Minitab, AutoCAD, SolidWorks, etc.
  • Proficient in statistical techniques for:
  • Analysis of data
  • Process characterization, development, and control (DOEs, SPC, etc.)
  • Equipment, process, and test-method validation (IQ, OQ, PQ, TMV)
  • Dimensional tolerancing and stacking
  • Proficient in Risk Analysis techniques (ISO 14971 or similar)
  • Excellent oral and written communication skills with customers and employees at all levels.
  • Excellent organizational skills.

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Experience

  • ISO 9001: 1 year (Preferred)

Work Location: In person

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Common questions

What is the salary for the Quality Engineer role at Nelipak?

The listed annual base salary range is $70K–$90K. This figure is taken from the posting itself.

Where is the Quality Engineer role at Nelipak based?

This role is based in Phoenix, AZ.

What degree is required for the Quality Engineer role at Nelipak?

This role requires a BS.

How many years of experience does this Quality Engineer role require?

The posting calls for 5–7 years of relevant experience.

What techniques or methods are required for this Quality Engineer role?

process validation (IQ/OQ/PQ), test method validation, DOE, SPC.