Tecomet Quality Engineer in Boulder, Colorado

Job SummaryThis position will provide support to manufacturing processes assigned.Manufacturing processes include machining and secondary processes. The personin this role will work independently requiring little guidance or supervision.Guidance is typically at the level of overall goal definition and specificwork objectives. It is the engineer s responsibility to figure out thedetails and a solution that is in compliance with medical device regulations.This role will also be responsible for participating in the development andmaturation of the Quality Management System within manufacturing operations.Essential Job Functions* Responsible for understanding the Tecomet Quality Management System(QMS) and medical device regulations.* Manage manufacturing validations which includes development of and authoringprotocols, working with operations to execute activities, perform analysisand write reports.* Perform measurement system studies.* Develop statistically driven manufacturing inspection plans and methods fornew products.- Create inspection plans from drawings and customer input, authorprocedures for inspection methods, and train manufacturing to those methods.* Project management skills and experience are required as you will leadprojects/teams.- Lead small teams of engineers and others in performing validations, thedevelopment of inspection techniques and other projects as assigned.* Identification, evaluation and qualification of suppliers in conjunctionwith QA resources for new products and processes.* Manage and/or participate in CAPA process to resolve manufacturing relatedissues.* Participate in complaint investigations.* Assist in resolution of customer quality and/or discrepant materialissues. Lead investigations and author rework Instructions, as necessary,for pro duct.* Work with cross functional teams to identify and implement processimprovements for existing products.* Lead cross functional teams in risk management activities according tomedical device requirements.* Other duties as assigned by management.Minimum Job Requirements* Bachelor s Degree in mechanical engineering or other applicable technicalfield and 3-5+ years related experience, or equivalent combination ofeducation and experience.* Preference will be given to candidates with working knowledge of ISO 13485and 21 CFR 820* Proficient with Microsoft Office products* Excellent communication skills (verbal, written, presentation) withinternal staff and customers* Excellent organizational skills.* Excellent teamwork skills.* Generally normal office hours but must be flexible with job hours to besuccessful in this position.Physical Requirements* Repetitive motions- Movements frequently and regularly required using the wrists, hands,and/or fingers* Visual abilities- Average visual acuity necessary to prepare or inspect documents orproducts, or operate machinery, including personal computer* Hearing- Able to hear average or normal conversation* Physical Strength- Sedentary work; sitting most of the time- Exerts up to 10 pounds of force occasionallyNote:This job description is only a summary of the typical functions of the job,not an exhaustive or comprehensive list of all possible jobresponsibilities, tasks, and duties. This job description does notrestrict management s right to assign or reassign duties andresponsibilities to this job at any time. Job descriptions are not intendedand do not create employment contracts.** Final candidate must undergo and s uccessfully complete a drug screen andbackground check **Equal Opportunity Employer M/W/Vets/Disabled