{"id":1695562,"url":"https://alion.io/job/resonetics-sr-quality-engineer","title":"Sr. Quality Engineer","company":{"id":3860882,"name":"Resonetics","domain":"resonetics.com","url":"https://alion.io/company/resonetics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Dayton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":84000,"max_usd":161000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2941},"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-02T12:02:36Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-02T12:02:36Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Overview\nResonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.\nThe Sr. Quality Engineer is a key contributing member of the Quality Assurance team, working to implement and maintain the Quality Management System (QMS) to ensure that the activities of the company are performed in compliance with the QMS and applicable regulatory requirements. The individual also serves as a key member of product development teams to perform activities related to design, development, manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. This person also works to identify deficiencies in quality system and device performance and recommend and implement corrective and preventive actions. This role reports to the Director of Quality Assurance and Regulatory Affairs.\nJoin Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.\nResponsibilities\nResponsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required.\nEnsure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process.\nCollaborate with the development engineering team(s) to create and/or update documentation to support Design Controls.\nAuthor protocols or provides support in performing qualification validation protocols in support of design control deliverables.\nConduct risk assessments of the design to determine ability to function as intended. Responsible for completion of risk analysis and mitigating actions.\nResponsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and design history files (DHF), device master records, etc.\nAs a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds.\nInteract with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.\nHelp create and implement and maintain product/process specifications, standards, and procedures to support QMS implementation and documentation. This involves writing and revising documents as necessary.\nMaintain QMS to ensure full compliance to all quality and regulatory requirements.\nManage the Document Control process and ensure all steps of this process are performed.\nProvide statistically valid sampling plans when required.\nWork closely with engineering in understanding, developing and executing statistically designed experiments.\nManage Training program, including maintenance of training records and monitoring training compliance.\nProcure and maintain external standards.\nDevelop incoming, in-process, and final inspection and quality plans.\nMaintain and/or support maintenance of the Non-Conforming Material and Corrective and Preventive Action System, including NCMR (disposition, review, and approval), CAPA (initiation, review, verification, and effectiveness check), Complaint Handling (handling, investigation, and reporting) to ensure timeliness of actions and tracking metrics to support management review.\nCollaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.\nSupport Equipment Calibration and Maintenance per the applicable procedures. Maintain accurate calibration records in accordance with internal requirements.\nMaintains detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.\nAssist in Incoming and Final Acceptance Activities by ensuring that proper documentation is maintained and preparing metrics as appropriate.\nAssist in the preparation of Management Review presentations and maintain accurate records of such.\nWorks closely with all team members in onboarding and assessment of new suppliers and oversees supplier quality program (supplier files, approved supplier list; supplier audits, supplier performance metrics, etc.).\nEnsures that all work satisfies the requirements of the company's Quality Manual. Continually looks for improvement and compliance improvement opportunities.\nComplete projects in a timely manner and consistent with company objectives.\nMentor junior engineers on quality system requirements.\nAny other duties as assigned.\nRequired Qualifications\n5+ years of experience in a Quality Engineering role.\nBachelor's degree or equivalent experience\nDemonstrated technical writing and communication skills. \nStrong attention to detail, organization, and verbal and written communication skills.\n\nAbility to interact with client companies in a professional manner. Demonstrated ability to lead product verification & validation activities.\n\nOrganized and able to self-manage project tasks.\n\nProficiency in use of Word, Excel, and PowerPoint.\n\nAbility to work under pressure, handle multiple projects, and meet aggressive deadlines.\n\nAbility to read and understand regulations, standards, and procedures.\n\nExperiences with analytical instrument calibration preferred.\n\nPhysical Demands\n Able to work in an office environment\nCompensation\nThe compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $78,000-$124,000.\n“For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.”","description_format":"text","description_chars":6598,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T12:02:36Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":30,"reasons":["conf:15","win:early"],"computed_at":"2026-10-03T03:27:42Z"},"pay":null,"html_url":"https://alion.io/job/resonetics-sr-quality-engineer","json_url":"https://alion.io/job/resonetics-sr-quality-engineer.json","meta":{"generated_at":"2026-10-03T03:27:42Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3210,"day_limit":5000,"remaining_today":1790,"minute_limit":60,"resets_at":"2026-10-04T00:00:00Z"}}}