Quality Control Associate
About The Position
Surmodics Services & Technologies ("SST") (formerly Biocoat) is committed to providing the best in developing, manufacturing, and applying coatings on medical devices. We are looking for a Quality Control Associate to be part of a positive team-oriented environment. Responsibilities: Responsibilities include, but are not limited to: Establish, execute, review, evaluate, and optimize laboratory procedures and policies Perform, record and report quality control inspections and testing Troubleshoot and participate in resolution of administrative or technical problems Review batch records and supporting documents for production activities and release of product Initiate, facilitate, assist, and review investigations and associated work for NCPs, CAPAs, ECOs, and failures for laboratory-related events Assist with purchase, use, storage, and management of laboratory inventory/supplies. Investigate customer complaints Coordinate Material Review Board (MRB) meetings and facilitate material and documentation dispositions, as needed Author and review quality procedures, templates, forms, and reports Communicate deficiencies, safety and/or compliance issues Compile data and report QMS metrics as required (e.g., special projects, product study, Management Review) Support audit preparation and performance audit activities
Requirements
- Bachelor’s degree in chemistry, biology, biomedical engineering, or similar Life Science field required
- 1 year of experience in a regulated manufacturing quality control lab preferred
- Prior experience with ISO 9001 or ISO 13485, and/or experience with QMS documentation and Good Document Practices highly desirable
- Ability to report, evaluate and interpret scientific data to be successful in this role
- Excellent math skills to adequately perform and interpret calculations and test parameters needed
- Analytical approach to problem solving; critical thinker; uses data to substantiate decision making
- Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation with extreme detail required
- Proficiency with Microsoft Word, Excel, and Outlook; Prior experience with eQMS or ERP systems highly desired
- Ability to complete assigned tasks in a timely manner with minimal day-to-day direction while meeting deadlines
- Strong interpersonal and communication skills (verbal/written)
- Ability to follow and adhere to all Safety guidelines and processes including wearing appropriate lab gowning and other PPE as required.
- The conditions herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.
Responsibilities
- Establish, execute, review, evaluate, and optimize laboratory procedures and policies
- Perform, record and report quality control inspections and testing
- Troubleshoot and participate in resolution of administrative or technical problems
- Review batch records and supporting documents for production activities and release of product
- Initiate, facilitate, assist, and review investigations and associated work for NCPs, CAPAs, ECOs, and failures for laboratory-related events
- Assist with purchase, use, storage, and management of laboratory inventory/supplies.
- Investigate customer complaints
- Coordinate Material Review Board (MRB) meetings and facilitate material and documentation dispositions, as needed
- Author and review quality procedures, templates, forms, and reports
- Communicate deficiencies, safety and/or compliance issues
- Compile data and report QMS metrics as required (e.g., special projects, product study, Management Review)
- Support audit preparation and performance audit activities
Benefits
- Competitive salary, eligible for a discretionary bonus
- Benefits (medical with HSA component, dental, vision, critical illness, and accident insurance)
- Life insurance, short- and long-term disability paid by the company
- Flexible Spending Accounts (FSAs)
- 401(k) plan with an immediate company match
- Paid time off
- Education Assistance Program
- Rewards and Recognition Program
- Parental Leave
- Employee Assistance Program
- Additional benefits such as the opportunity to leave early on Friday's, business casual dress, friendly work environment, and fun company events.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
