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 Whole Products Solution organization to achieve quality and regulatory compliance with the desired customer outcome.
The Operations 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 Whole Products Solutions organization to achieve quality and regulatory compliance with the desired customer outcome.
Operations Quality Engineering (50%)
- Ensure products are manufactured according to the defined requirements
- Initiate and contain nonconforming materials and perform evaluations of nonconforming material reports
- Support and lead operation improvement and efficiency initiatives
- Support and lead investigations to resolve quality issues
- Support and lead customer complaint evaluations and corrective actions
Product Development (25%)
- Participate in product development discussions and sub-team activities
- Support new product development teams including document revision, review and approval
- Support and lead risk management activities
- Support design transfer activities including IOQ review and approval for new equipment
Purchasing & Supplier Controls (5%)
- Support supplier evaluations and material qualifications
- Assist with supplier audits and report review
- 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 (10%)
- Analyze engineering change requests
- 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
Quality Systems (10%)
- Provide internal and external audit support
- Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs
- Four-year technical degree with minimum 4 years’ experience in a Quality Engineering role
- ASQ Quality Engineering certification desired
- Experience with QSR and ISO quality systems
- 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
- Ability to generate 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.