New

QA - Quality Assurance Engineer

IPG Photonics
vision insurance, paid holidays, sick time, tuition reimbursement, 401(k)
United States, Massachusetts, Oxford
50 Old Webster Road (Show on map)
Nov 04, 2025
Back 9h QA - Quality Assurance Engineer #25-741 Apply X Facebook LinkedIn Email Copy Job Description Job Summary The Quality Assurance (QA) Engineer is responsible for collaborating with suppliers, development teams, and manufacturing teams to perform QA activities. This includes, but is not limited to, supporting Design Transfer processes and ensuring quality standards are met throughout the product lifecycle. Key Responsibilities: Supplier Management & SCAR Support Support SCAR processes and manage nonconformances and rework evaluations for assigned suppliers. Handle supplier-related internal NCMRs, CAPAs, and complaint corrective actions. Manufacturing & Process Support Provide sustaining support for process improvements and design changes transitioning into manufacturing. Assist in design transfer activities and maintain manufacturing documentation (DHRs, routers, BOMs, specifications). Material & Product Quality Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues. Perform incoming inspection reviews and disposition of components and subsystems. Validation & Risk Management Evaluate proposed changes to processes, equipment, or materials for validation impact. Maintain and create product-specific risk files in accordance with ISO 14971. Calibration & Documentation Assist with calibration system maintenance. Develop and revise procedures, work instructions, and test methods. Quality Systems & Compliance Document activities in compliance with medical standards and regulations. Lead investigations into quality issues, complaints, and audit findings. Support CAPA processes and promote QMS awareness and improvement initiatives. Supplier Audits & Approvals Support management of new and approved suppliers. Participate in internal and supplier audits. Problem Solving & Decision Making Use root cause analysis and problem-solving tools to implement corrective actions. Make data-driven decisions and propose solutions based on calculated risks. Requirements Education and Experience Bachelor's degree in engineering or a related technical field 3-5 years of manufacturing quality experience within the medical device industry Experience executing process validation and test method validation / Gage R&R activities Experience with risk management activities per ISO 14971 Required Skills and Abilities Working knowledge of advanced statistical methods, including Hypothesis testing, Design of Experiments (DOE), ANOVA, R&R studies, Capability analysis, Tolerance interval analysis, Power and sample size determinations Proficiency with statistical software tools (e.g., Minitab) is preferred Extensive working knowledge of 21 CFR Part 820, ISO 13485 Strong proficiency in Microsoft Word and Excel Hands-on experience with manufacturing processes such as Electro-mechanical assembly, ESD controls, Cabling, Clean room operations, Labeling, Sterilization, Fiber optics Strong documentation skills for protocol and report generation and review Ability to analyze quality data and trends to identify improvement opportunities Prior start-up experience is a plus Location(s) Employment Type Exempt US Benefits Information Pay Range: The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience. Other Compensation: Employees in this role are eligible for additional rewards which could include: Annual Discretionary Bonus or Sales Bonus as Applicable Equity awards as applicable Benefits Provided: All Regular* US employees receive: Paid vacation time accrued based on years of service Paid sick time 12 (twelve) Paid Holidays Each Calendar Year Prorated for part time schedules Additional Benefits Offered: IPG also offers access to: Medical, dental, and vision insurance plans with options for HSA/FSA Dependent Care FSA Paid Basic Life and AD&D Insurance Short-term and Long-term Disabilityinsurance 401(k) plan with Company matching Employee Stock Purchase Plan (ESPP) Tuition Reimbursement Program Employee Assistance Program (EAP) Adoption Assistance Pet Insurance Parental Bonding Leave Bright Horizons Backup Care Bright Horizons College Coach Must work at minimum, 20 hours/week. Deadline and How to Apply This job posting will remain active until a candidate is identified and/or the Company rescinds the job posting. For full consideration, please click on the link to apply.