Together, we ensure that our patients receive professional support, hands-on guidance, and reliable delivery of essential medical supplies. We are looking to strengthen our team and are seeking a Head of Continuous Improvement (m/w/d) (Certified Master Black Belt) - 25% travel to join us.
Strong analytical and problem-solving skills. Ability to travel up to 30%. Benefits Medical, Dental, and Vision insurance available after 30 days of employment. Generous Educational Reimbursement program. Company-sponsored Life and Disability Insurance.
Strong analytical and problem-solving skills. Ability to travel up to 30%. Benefits Medical, Dental, and Vision insurance available after 30 days of employment. Generous Educational Reimbursement program. Company-sponsored Life and Disability Insurance.
At Oxford Instruments Plasma Technology, we provide tools for the engineering of micro- and nano-structures, with customers using our process solutions to research and produce materials and semiconductors vital for everything from medical devices and diagnostics to electric cars and quantum computers. Benefits: In addition to a competitive starting salary, Oxford Instruments also offers structured career development opportunities, a good work-life balance, private healthcare, a share incentive plan, 25 days annual leave, half-days on Fridays, a defined contribution Group Personal Pension Plan, and a flexible benefits package that you can tailor to your own requirements.
Das Unternehmen bietet Raum für Menschen, die Verantwortung übernehmen möchten und Freude daran haben, an anspruchsvollen, zukunftsorientierten Technologien mitzuwirken Weiterentwicklung eines schlanken, risikobasierten Qualitätsmanagementsystems (ISO 13485, AI Act) Sicherstellung regulatorischer Anforderungen für aktive Medizinprodukte, sterile Produkte sowie Software as a Medical Device (SaMD) Vorbereitung, Koordination und Begleitung internationaler Zulassungs- und Registrierungsprozesse (EU/MDR, USA/FDA) inkl.
Das Unternehmen bietet Raum für Menschen, die Verantwortung übernehmen möchten und Freude daran haben, an anspruchsvollen, zukunftsorientierten Technologien mitzuwirken Weiterentwicklung eines schlanken, risikobasierten Qualitätsmanagementsystems (ISO 13485, AI Act) Sicherstellung regulatorischer Anforderungen für aktive Medizinprodukte, sterile Produkte sowie Software as a Medical Device (SaMD) Vorbereitung, Koordination und Begleitung internationaler Zulassungs- und Registrierungsprozesse (EU/MDR, USA/FDA) inkl.
About us Your Contribution Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure Lead/support validation and qualification for equipment, products, processes, etc.Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed Promote safety and EHS and adhere to all Company policies, procedures and guidelines Your Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach
About us Our Business Unit Lighting and Imaging offers smart solutions for light delivery and image transmission in demanding environments — from medical devices, industrial, and safety applications to aviation and automotive. With manufacturing sites in Europe and North America, and supported by SCHOTT’s global sales network, we are a leading supplier of high-quality fiber optic and LED components.