Medical Device Quality Engineer

Insight Global; Pleasant Prairie (WI); On-site; USD 53,000 - 68,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA

FSA

401k with employer matching

Paid time off

Paid sick leave

Job summary

Insight Global is seeking a Medical Device Quality Engineer II for the Pleasant Prairie, WI site. The role onsite supports process improvements, risk management, audits, and nonconforming materials to sustain product quality in a regulated environment.

The incumbent will manage quality system documents, drive CAPA, release change-controlled documents, and act as a quality system owner across design control and manufacturing processes, collaborating with cross-functional teams.

Qualifications

• 5 to 8 years of relatable experience in a regulated industry is required.
• A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.
• Well-rounded knowledge of ISO 13485:2016 and FDA QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Mechanical aptitude with manufacturing experience.
• Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos.
• Must possess the ability to work semi-independently with little daily input from a manager.
• Experienced in statistical analysis.
• Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
• Well versed in data management and graphical presentation of data.
• Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
• Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization

Responsibilities

• Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements.
• Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols).
• Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes.
• Quality Representative for Risk Management Activities for existing products.
• Provide interpretive assistance, to all departments, regarding quality documents.
• Support training on Manufacturing and Quality System documents.
• Conduct customer complaint investigations, interface with customers to gather necessary details, determine root cause and implement corrective and preventive actions.
• Interface with Engineering to drive continual improvement on existing manufacturing processes.
• Quality Representative for Design Control Activities for existing product lines.
• Release documents via the change control process as necessary. Train others where required.
• Prepare quality related deliverables in a timely manner.
• Participate in CAPA root cause investigation and actions implementation.
• Implement ongoing quality improvement processes working with cross functional teams.
• Acts as a consultant for areas related to his/her expertise.
• Performs other related duties as assigned by management.
• Quality Representative for contract review activities on existing products.
• Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products.

Skills

Root-cause analysis

Manufacturing experience

ISO 13485 knowledge

FDA QSR knowledge

Written and verbal communication

Data analysis

Microsoft Excel

Problem solving

Education

Bachelor's degree in engineering or related discipline

Tools

Microsoft Windows

Outlook

Word

Microsoft Project

Job description

Medical Device Quality Engineer - Job Opportunity

Location: Fully Onsite in Pleasant Prairie, WI

Shift: 1st Shift (M-F)

Compensation: 38.46/hr to $49hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Required Skills & Experience

• 5 to 8 years of relatable experience in a regulated industry is required.
• A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.
• Well-rounded knowledge of ISO 13485:2016 and FDA QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Mechanical aptitude with manufacturing experience.
• Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos.
• Must possess the ability to work semi-independently with little daily input from a manager.
• Experienced in statistical analysis.
• Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
• Well versed in data management and graphical presentation of data.
• Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
• Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization

Job Description

Our client, a Manufacturer of Medical Devices & Flexible Packaging Solutions, is looking to add a Quality Engineer II to their site in Pleasant Prairie, WI. The Quality Engineer II is responsible for supporting process improvements, risk management activities, complaint process, design control activities, customer/ISO/FDA audits and non- conforming material as it relates to sustaining products. The Quality Engineer II participates in review and approval of Quality System documents, resolves quality issues and ensure quality control of products and processes, in compliance with all applicable company policies and procedures. The Quality Engineer II may be asked to be a quality system process owner in which this role will actively manage one or multiple key components of the quality system.

DUTIES AND RESPONSIBILITIES:

• Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements.
• Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols).
• Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes.
• Quality Representative for Risk Management Activities for existing products.
• Provide interpretive assistance, to all departments, regarding quality documents.
• Support training on Manufacturing and Quality System documents.
• Conduct customer complaint investigations, interface with customers to gather necessary details, determine root cause and implement corrective and preventive actions.
• Interface with Engineering to drive continual improvement on existing manufacturing processes.
• Quality Representative for Design Control Activities for existing product lines.
• Release documents via the change control process as necessary. Train others where required.
• Prepare quality related deliverables in a timely manner.
• Participate in CAPA root cause investigation and actions implementation.
• Implement ongoing quality improvement processes working with cross functional teams.
• Acts as a consultant for areas related to his/her expertise.
• Performs other related duties as assigned by management.
• Quality Representative for contract review activities on existing products.
• Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products.

Potential Quality System Process Owner for the following (but not limited to):

• Non-conforming Reports (NCR)
• Customer Complaints
• Corrective and Preventive Actions (CAPA)