Senior Quality Assurance Manager

SummaryThe Senior QA Manager is a quality professional with day to day responsibility for site management. From a quality perspective, this role involves designing, planning, prioritizing, executing, reviewing, and reporting results of tests performed in the QA lab as well as other related duties necessary to operate within a highly regulated environment such as supporting quality events (audits, corrective actions, investigating nonconformances), maintaining calibrations, document control, and training. From a site management perspective: the Supervisor is the most senior NextBeam person onsite and has responsibility for assuring operations run as planned in conjunction with our manufacturing partner.Essential Duties: QualityEstablish and maintain good technical understanding of relevant industry standards and regulations (ISO 13485, ISO 11137 series, ISO 11737 series, ASTM 51649, ASTM 52303) in order to design and perform testing with appropriate test methods, sample sizes, statistical techniques, and acceptance criteria.Collect, analyze, and report data to release / reject product batches and other studiesMaintain calibration of laboratory equipment and toolsInvestigate, root-cause analyze, and provide disposition when quality events occurMaintain document control including developing new and updated procedures, forms, templates and recordkeeping systemsSupport audits by customers, regulators, and other groups including understanding and communicating how we meet applicable requirements, planning and implementing corrective actionsMaintain a high level of quality and integrity even under challenging conditions such as undesirable test results or during customer or regulatory auditsCollaborate with other functions to convey the importance of quality control including how quality control affects and is affected by other functionsSchedule, prioritize, and communicate status of testing according to a variety of factors including internal, customer, and compliance requirementsMaintain inventory of lab supplies and consumablesMaintain accuracy and completion of sample inventory and other logsAssist with data trending and analysis for monitoring validated processes and supporting changes when necessaryAssist with establishing schedule and responsibilities for lab personnel to drive customer and employee satisfactionParticipation in industry standards development and updating internal documentation for continuing compliance as standards and regulations are revisedEssential Duties: Operations & LeadershipUnderstand and be able to operate NextBeam’s Enterprise Resource Planning (ERP) system to receive, work order, and invoice jobsMaintain strong and proactive communication with our onsite manufacturing partnerAssure that the small (1-3 person) onsite NextBeam team is trained and and organizedProvide first-line guidance to help junior staff perform their designated tasksAssure NextBeam meets its obligations to customers in conjunction with our Customer Service teamRequired Qualifications:College diploma or equivalent3+ years in quality control or a related functionAbility to communicate with native or bilingual proficiency in English including reading, writing, listening, and speaking in a professional and technical manner with internal and external groupsVery strong skills with Microsoft Office applications (Word, Excel)Ability to lift 30lbs., sit or stand for long periods of time.Strong skills in mathematics and statisticsPreferred Qualifications:AAMI CISS-RAD certificationIndustry training for quality control, document control, or auditingExperience working in a highly regulated environment (medical device, pharmaceutical, aerospace, semiconductor or similar)Working knowledge of good documentation practices (GDP), good manufacturing practices (GMP), quality systems (ISO 9001 or ISO 13485)Experience working in a laboratory environment and using lab equipmentExperience with performing and maintaining calibrations or other verification / validation processesUniversity courses in statistics and/or calculusSix sigma certification (yellow, green, black) for statistical analysisWork Environment:Works in a variety of environments including laboratory, warehouse, and officeOccasional exposure to dust, heat, humidity, and solid or gaseous materials with special handling requirementsOccasional (5-10%) travel for industry conferences, training, customers, or other corporate functionsEmployment Type: Full-Time, Non-Exempt (Hourly)Benefits Offered: Paid Time Off, Paid Holidays, Medical, Dental and Group Vision Insurance,401k with Company match, gym membership reimbursement, casual work environment and excellent career growthJob Type: Full-timePay: $90,000.00 - $110,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programHealth insurancePaid time offReferral programEducation:Bachelor's (Required)Experience:Quality Control: 3 years (Required)Management: 2 years (Required)License/Certification:AAMI CISS-Rad (Preferred)