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Sr Manufacturing Engineer- Automation
Lake Geneva, WI
Job Description
Sr Manufacturing Engineer- Automation
**job details:**
+ location:Lake Geneva, WI
+ salary:$75,000 - $105,000 per year
+ date posted:Thursday, June 3, 2021
+ job type:Permanent
+ industry:Manufacturing
+ reference:844880
**job description**
Sr Manufacturing Engineer- Automation
job summary:
Rapidly growing medical manufacturing company located in the Lake Geneva, Wisconsin area is currently looking for a Sr Manufacturing Engineer with experience with automated equipment, process improvements, writing work instructions, and IQ / OQ / PQ validations. The company has continued to have year over year growth in the double digits and this is an excellent opportunity to join a company on the cutting of edge of new technology.
location: Lake Geneva, Wisconsin
job type: Permanent
salary: $75,000 - 105,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
+ Interface with all departments to define validation project scope, responsibility, accountability, actions/functions, timelines, and goals.
+ Work closely with Quality and Regulatory Manager to develop project processes for IQ OQ PQ customer specific requirements, develop procedures, SOPs, protocols for project management.
+ Develop and manage validation master list activities to support IQ OQ PQ validations and qualifications as required. Prepare and perform process product qualifications as outlined in a customer specific validation protocol. Ensures project development and IQ OQ PQ practices meet FDA/medical regulatory requirements.
+ Work Instructions and IQ OQ PQ validation activities.
+ Streamline and manage IQ OQ PQ project process steps to ensure they are clear and concise; report on validation status and work with all departments to achieve IQ OQ PQ validations continuous progress, meet deadlines and exceed customer satisfaction.
+ Coordinate changes to IQ OQ PQ validation functions within all depts and customers.
+ Create/Write and circulate all IQ OQ PQ protocols and SOPs, Work Instructions to responsible departments (including customers & suppliers) including routing management signature of approval.
+ Provide input and output for validation testing to support product development; during R&D activities identify project risks that can affect form, fit, function and regulatory requirements for design, manufacturing, and quality.
+ Interface with quality dept to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed.
+ Perform functions as directed to support quality management and company management team.
**Education and Experience Requirements:**
+ Has minimum of two-year degree in relevant field or equivalent required with bachelor's degree preferred, or applicable accredited certifications pertaining to job responsibilities.
+ Minimum of three years of manufacturing experience with project coordinator and IQ OQ PQ responsibilities preferably in a medical ISO 13485:2016 environment
+ Demonstrated knowledge of project coordination methodology and validation methods (IQ/OQ/PQ) statistical process control, application of statistical techniques, and meeting regulatory requirements per CFR820
+ Experience with Six Sigma, process capability statistics, AQL and background in medical environment with FDA requirements strongly preferred
+ Ability to effectively use statistics associated with ensuring product coordination and IQ OQ PQ functions
qualifications:
+ Experience level: Experienced
+ Minimum 5 years of experience
+ Education: Bachelors (required)
skills:
+ Manufacturing
+ Process Improvement
+ Lean
+ Process Improvement
+ Process Improvement
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Summary
Company
Randstad
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
20+ years
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