Quality Engineer POST NUMBER: 468288
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.
Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
EEO Notice
Vaco by Highspring is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law.
Vaco by Highspring and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco by Highspring and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR@vaco.com .
Vaco by Highspring also wants all applicants to know their rights that workplace discrimination is illegal.
By submitting to this position, you agree that you will be giving Vaco by Highspring the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco by Highspring about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco by Highspring agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal.
Privacy Notice
Vaco by Highspring and its parents, affiliates, and subsidiaries (“we,” “our,” or “Vaco by Highspring”) respects your privacy and are committed to providing transparent notice of our policies.
- California residents may access Vaco by Highspring HR Notice at Collection for California Applicants and Employees here.
- Virginia residents may access our state specific policies here.
- Residents of all other states may access our policies here.
- Canadian residents may access our policies in English here and in French here.
- Residents of countries governed by GDPR may access our policies here.
Pay Transparency Notice
Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to:
- the individual’s skill sets, experience and training;
- licensure and certification requirements;
- office location and other geographic considerations;
- other business and organizational needs.
With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.