We're looking for a Quality Engineer who can bring strong technical expertise, problem?solving skills, and a solid understanding of industry standards to a fast?paced product development and manufacturing environment.
Responsibilities- Lead validation and qualification activities for complex products through new product introduction (NPI) and transfer workflows.
- Act as the lead Quality Engineer on development projects, guiding Design History File (DHF) and Device Master Record (DMR) documentation and planning product builds.
- Drive risk management activities, develop risk documentation (e.g., PFMEAs), and implement mitigation strategies.
- Lead root?cause investigations using structured problem?solving tools and verify effectiveness of corrective actions.
- Develop and improve test methods and support equipment, process, and product validation efforts.
- Create, review, and maintain process control plans and quality documentation aligned with regulatory requirements.
- Support design controls in compliance with ISO 13485 and 21 CFR 820, including verification, validation, and related design review activities.
- Partner with engineering, operations, customers, and suppliers to transition new products into manufacturing and sustain ongoing production processes.
- Improve and standardize manufacturing process instructions and quality procedures; provide training when needed.
- Develop metrology tools and oversee Gage R&R studies to ensure accurate measurement systems.
- Review nonconformances, approve dispositions, and support corrective and preventive action (CAPA) activities.
- Analyze production and validation data to identify trends and opportunities for process improvement.
- Support supplier quality tasks, including communication with customer quality teams and supplier qualification when required.
- Assist with troubleshooting production issues and supporting manufacturing and development processes.
- Ensure calibration and maintenance procedures are followed for equipment used in validation and production.
- Prepare deviations, change notices, validation protocols, and related quality documentation.
Qualifications
- 2+ years of Quality Engineering experience in medical device manufacturing, a start?up environment, or comparable engineering role.
- Bachelor's degree or equivalent experience.
- Working knowledge of ISO 13485, 21 CFR 820, and quality system regulations.
- Experience creating technical and quality?related documentation.
- Strong communication, technical writing, and interpersonal skills when interacting with customers and suppliers.
- Familiarity with statistical analysis tools such as Minitab; experience with Gage R&R is a plus.
- Ability to support supplier audits, qualification activities, and ongoing quality communication.
Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs. With that said, as required by local law in geographies that require salary range disclosure, Vaco/Highspring notes the salary range for the role is noted in this job posting. The individual may also be eligible for discretionary bonuses, and can participate in medical, dental, and vision benefits as well as the company's 401(k) retirement plan.
