EdenPrairieRecruiter Since 2001
the smart solution for Eden Prairie jobs

Senior Quality Engineer

Company: Jobleads
Location: Eden Prairie
Posted on: May 3, 2021

Job Description:

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Senior Quality Engineer is responsible for providing quality engineering support for all phases of the product lifecycle at Surmodics. This position will support the development and facilitation of quality engineering principles throughout the organization to achieve quality and regulatory compliance with the desired customer outcome. Responsibilities Product Development (% Varies) Provide technical expertise in design controls and risk management Develop risk management plans and lead risk management activities Draft documents and provide technical review for document revision, review and approval Maintain design history file and lead design review discussions Support supplier evaluations and material qualifications Lead supplier audits, draft final reports, and coordinate audit finding closure Provide technical assistance for first article inspections and ongoing performance monitoring Support the investigation and resolution of issues related to supplied components and services Continuation Engineering (% Varies) Support process and design change activities Support product stability programs by reviewing protocols and reports Analyze customer change notification requirements to support internal process changes Lead discussions with customers for addressing quality issues and change notifications Operations Quality Engineering (% Varies) Ensure products are being manufactured according to the defined requirements Initiate and contain nonconforming materials and perform evaluations of nonconforming material reports Lead and support operation improvement and efficiency initiatives Lead investigations to resolve quality issues Lead customer complaint evaluations and corrective actions Provide Quality support for Calibration and Preventative Maintenance Systems Provide Quality support for Infrastructure changes (e.g. facility, cleanroom, environmental monitoring) Quality Systems (% Varies) Develop and maintain key quality metrics Present trending data to management during management review Review current regulations and requirements and recommend changes to quality system Develop and maintain effective internal audit program Lead internal and external audit programs Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs Validation (Software, Process and Systems) (% Varies) Provides technical support to project teams Drafts and approves protocols and reports Ensures compliance with applicable standards Performs risk management activities throughout the software lifecycle Minimum Qualifications Four-year technical degree with minimum 8 years' experience in a Quality Engineering role ASQ Quality Engineering certification desired ASQ Software Quality Engineering certification required (if assigned) Experience and training in process and equipment validation Extensive experience with QSR and ISO quality systems Extensive experience with statistical techniques, measurement/trending and SPC tools Strong attention to detail Proficient computer skills- Microsoft Word, Access and Excel, statistic software (jmp, minitab) Excellent analytical and problem solving skills Ability to read and follow detailed instructions including generating detailed instructions Excellent written and verbal communication skills Excellent interpersonal skills Ability to prioritize activities relative to competing demands from multiple sources Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Are you legally authorized to work in the US? * -- Do you require sponsorship now or in the future? * -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Surmodics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to: Autism Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS Blind or low vision Cancer Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or hard of hearing Depression or anxiety Diabetes Epilepsy Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome Intellectual disability Missing limbs or partially missing limbs Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS) Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Jobleads, Eden Prairie , Senior Quality Engineer, Other , Eden Prairie, Minnesota

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Minnesota jobs by following @recnetMN on Twitter!

Eden Prairie RSS job feeds