Overview
Quality Systems Engineer Jobs in Acton, MA at SARACA
Title: Quality Systems Engineer
Company: SARACA
Location: Acton, MA
Company Description
SARACA is a global engineering R&D services company partnering with over 25 Fortune 500 customers across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. As an ISO 13485-certified organization, SARACA specializes in developing innovative medical devices, with expertise in embedded software, UI/UX, mechanical systems, product testing, and regulatory compliance such as IEC 62304 and EU MDR. Backed by a technically skilled team of over 400 engineers and consultants, SARACA delivers tailored product engineering solutions globally. The company fosters a culture of innovation and continuous learning, promoting opportunities and success for both its clients and employees.
Key Responsibilities
- Review and revise process failure mode and effect analysis (pFMEA) documentation for the medical device products
- Evaluate and qualify product and process rework activities in accordance with approved protocols and applicable regulatory requirements.
- Review, revise, and update controlled documents such as SOPs, work instructions, protocols, and batch records.
- Support risk assessments and impact evaluations for historical deviations and nonconformances.
- Ensure all documentation reflects traceability, scientific justification, and alignment with regulatory expectations.
- Collaborate with cross-functional teams, including Engineering, QA, and Manufacturing, to obtain required technical inputs.
- Participate in root cause investigations and assist in the implementation of corrective and preventive actions (CAPAs).
- Maintain comprehensive records of remediation work and ensure timely completion of assigned deliverables.
Qualifications
- Bachelor’s degree or above in Mechanical Engineering, Materials Science, Biomedical Engineering, Quality Management, or related fields.
- Minimum 5 years of quality engineering or management experience in the medical device or related industry, with solid knowledge of FDA, ISO 13485 and GMP regulations.
- Proficient in DHR review processes and failure analysis methodologies, with strong problem-solving skills.
- Skilled in quality tools (FMEA, SPC, 8D, QC tools) and capable of independently preparing analysis reports.
- Familiar with common measurement instruments and laboratory operations.
- Strong communication and teamwork skills; able to work under pressure.
- Advanced data analysis skills; proficient in Excel, Minitab, or similar tools.
- Experience with medical device registration, quality system audits, or supplier management is a plus.
- Continuous improvement mindset and ability to proactively drive projects.
- Excellent English reading, writing, and speaking skills are mandatory. Ability to read and draft technical documents and communicate with global teams in English is required.
