Quality Engineer - Norristown, PA
Medline · Norristown, PA
- Level
- Engineer
- Team
- Quality
- Base pay
- $79k–$119k
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 10 days ago
The role in 30 seconds
An engineer-level quality role at Medline (medical devices) in Norristown, PA.
- They ask for
- 2+ years · degree required
- Tools it names
- SPC, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Supplier quality
- Base pay
- $79k–$119k
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- 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, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 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.
About the role
Job Summary
Under broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.
Job Description
Responsibilities
- ◆Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- ◆Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
- ◆Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
- ◆Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required. Coordinate product testing with internal and external laboratories as required.
- ◆Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
- ◆Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Education
- ✓Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
Work Experience
- ✓At least 2 years of experience in the Quality or Engineering.
Education
- ✓None
Work Experience
- ✓At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
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Certification / Licensure
- •None
Knowledge / Skills / Abilities
- •Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
- •Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
- •Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
- •Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
- •Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
- •Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
- •Position requires up to 15% travel
Certification / Licensure
- •None
Knowledge / Skills / Abilities
- •None
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.