Senior Quality Engineer

Company: SurModics
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.ResponsibilitiesProduct Development (% Varies)Provide technical expertise in design controls and risk managementDevelop risk management plans and lead risk management activitiesDraft documents and provide technical review for document revision, review and approvalMaintain design history file and lead design review discussionsSupport supplier evaluations and material qualificationsLead supplier audits, draft final reports, and coordinate audit finding closureProvide technical assistance for first article inspections and ongoing performance monitoringSupport the investigation and resolution of issues related to supplied components and servicesContinuation Engineering (% Varies)Support process and design change activitiesSupport product stability programs by reviewing protocols and reportsAnalyze customer change notification requirements to support internal process changesLead discussions with customers for addressing quality issues and change notificationsOperations Quality Engineering (% Varies)Ensure products are being manufactured according to the defined requirementsInitiate and contain nonconforming materials and perform evaluations of nonconforming material reportsLead and support operation improvement and efficiency initiativesLead investigations to resolve quality issuesLead customer complaint evaluations and corrective actionsProvide Quality support for Calibration and Preventative Maintenance SystemsProvide Quality support for Infrastructure changes (e.g. facility, cleanroom, environmental monitoring)Quality Systems (% Varies)Develop and maintain key quality metricsPresent trending data to management during management reviewReview current regulations and requirements and recommend changes to quality systemDevelop and maintain effective internal audit programLead internal and external audit programsProvide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAsValidation (Software, Process and Systems) (% Varies)Provides technical support to project teamsDrafts and approves protocols and reportsEnsures compliance with applicable standardsPerforms risk management activities throughout the software lifecycleMinimum QualificationsFour-year technical degree with minimum 8 years' experience in a Quality Engineering roleASQ Quality Engineering certification desiredASQ Software Quality Engineering certification required (if assigned)Experience and training in process and equipment validationExtensive experience with QSR and ISO quality systemsExtensive experience with statistical techniques, measurement/trending and SPC toolsStrong attention to detailProficient computer skills- Microsoft Word, Access and Excel, statistic software (jmp, minitab)Excellent analytical and problem solving skillsAbility to read and follow detailed instructions including generating detailed instructionsExcellent written and verbal communication skillsExcellent interpersonal skillsAbility to prioritize activities relative to competing demands from multiple sourcesSurmodics 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 DefinitionsIf 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 selectForm CC-305OMB Control Number 1250-0005Expires 05/31/2023Voluntary 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:AutismAutoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDSBlind or low visionCancerCardiovascular or heart diseaseCeliac diseaseCerebral palsyDeaf or hard of hearingDepression or anxietyDiabetesEpilepsyGastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndromeIntellectual disabilityMissing limbs or partially missing limbsNervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depressionDisability Status Please select1 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.SDL2017

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