Quality Engineer
Quality Engineer
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$ 96000 - 104000
1 Vacancy
Job Description
ABOUT SANISURE
SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs including monoclonal antibodies cell therapies gene therapies and vaccines. With operations in the U.S. and in Europe SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines.
We continue to be on a robust growth trajectory via both organic and inorganic growth as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.
Our primary offering includes high-value assembly solutions and a portfolio of market-leading products including PharmaTainer bottles and carboys and related assemblies Mixed4Sure mixing solutions Flex4Sure bags and bag assemblies Fill4Sure needles and needle assemblies fittings clamps and a wide range of silicone braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications such as cell and gene therapies.
SaniSure is a high-growth nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!
SUMMARY:
The Quality Engineer works closely withOperationsManufacturing Engineering R&D and Quality teams across the organization to lead and drive qualitythrough process improvement assessment and continuous improvement.The QualityEngineer will be the key point of contact forquality-related issues inprocess nonconformance manufacturingworkflowsand qualityproviding leadership in project management and technicalareasfor improvementsandenhancementsof process and testing requirements.The Quality Engineer will be the primary contactresponsiblefor quality events related to in-the-market defects and their corresponding root cause analysis and CAPA (Corrective Action & Preventative Action).
ESSENTIAL FUNCTIONS
- Lead quality investigations related to in-the-market defects toidentifyrootcauseand implement corrective actions and preventative actions.
- Colloboratewith cross-functional teams to investigate failure modes and execute impact assessments to ensureappropriate countermeasuresare developed and launched.
- Interface with customers and suppliers to address non-conformancesidentifiedduring manufacturing.
- Lead process improvement initiatives utilizingStatistcalProcess Control (SPC) and Six Sigmamethodologysuch as 5S Value Stream Mapping Control Plans PFEMA and Process Mapping.
- LeadManufacturing Quality Assurance aspects ofprocess controlinitiatingprojects to ensure thattargeted processflows areeffective andachieves operational requirementsand provide guidancetoSMEson root cause and corrective action (RCCA) activities.
- Recommend process improvements to management andexecuteto ensure consistent implementation of internal requirements and external regulations and standards.
- Providestatus reportingregardingmanufacturing processes deliverable dependenciesrisksand issues communicating across teams and management.
- Advisemanufacturingand qualityteamson the implementation of international standards (ISO9001regulatorystandards etc.) as they relate to manufacturing ofproductand Good Documentation Practices (GDP).
- Participate in the investigations and dispositions of product non-conformances and changes CARs andMRB.
- Generateandmaintainprocedures work instructions and forms as necessary to ensure standardization of practices acrossSaniSure.
- Implement required changes to existing training programs andassistin training staff members.
- Perform other tasks as assigned.
QUALIFICATIONS:
- Bachelors degree in Business Sciences or Engineering
- 5yearsof experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.
- 5 years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions change control quality audits and validation of manufacturing processes or product development in a pharmaceutical or medical device environment.
- Strong understanding of global pharmaceutical and biotechnology product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
- Ableto drivecontinuousimprovement through collaboration and consensus building.
- Proficient problem-solving skills using continuous improvement tools; certificationdesiredin ASQ Green Belt Lean or equivalent.
- Demonstratedproficiencyin multiple quality systems including exception management change control document control product release etc. with strong decision-making skillsutilizingrisk management.
- Quality System Knowledge (e.g.ISO 9001ISO 13485).
- Advanced skills with MS Office software are preferred.
- Abletoleadchange environment across multiple sites and customers globally.
- Ableto communicate effectively verbally and in writing anddemonstrategood interpersonal skills interdepartmentally and with external vendorscontractors and customers.
- Must be able to work effectively and efficiently in a team environment.
SaniSure is an Equal Employment Opportunity Employer.
SaniSure does not unlawfully discriminate on the basis of the race religion color national origin citizenship ancestry physical or mental disability legally protected medical condition (cancer-related or genetic characteristics or any genetic information) marital status sex gender sexual orientation gender identity gender expression pregnancy age military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Employment Type
Full-Time
