Quality Engineer

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 with Operations, Manufacturing Engineering, R&D and Quality teams across the organization to lead and drive quality through process improvement assessment and continuous improvement. The Quality Engineer will be the key point of contact for quality-related issues in process nonconformance, manufacturing workflows and quality providing leadership in project management and technical areas for improvements and enhancements of process and testing requirements. The Quality Engineer will be the primary contact responsible for 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 to identify root cause and implement corrective actions and preventative actions. 
• Colloborate with cross-functional teams to investigate failure modes and execute impact assessments to ensure appropriate countermeasures are developed and launched.  
• Interface with customers and suppliers to address non-conformances identified during manufacturing. 
• Lead process improvement initiatives utilizing Statistcal Process Control (SPC) and Six Sigma methodology such as 5S, Value Stream Mapping, Control Plans, PFEMA, and Process Mapping.
• Lead Manufacturing Quality Assurance aspects of process control, initiating projects to ensure that targeted process flows are effective and achieves operational requirements, and provide guidance to SME’s on root cause and corrective action (RCCA) activities.
• Recommend process improvements to management and execute to ensure consistent implementation of internal requirements and external regulations and standards.
• Provide status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and management.
• Advise manufacturing and quality teams on the implementation of international standards (ISO 9001, regulatory standards, etc.) as they relate to manufacturing of product and Good Documentation Practices (GDP).
• Participate in the investigations and dispositions of product, non-conformances and changes, CARs and MRB.
• Generate and maintain procedures, work instructions and forms, as necessary to ensure standardization of practices across SaniSure.
• Implement required changes to existing training programs and assist in training staff members.
• Perform other tasks as assigned.

QUALIFICATIONS:

• Bachelor’s degree in Business, Sciences or Engineering  
• 5  years of 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.
• Able to drive continuous improvement through collaboration and consensus building.
• Proficient problem-solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.
• Demonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management.
• Quality System Knowledge (e.g. ISO 9001, ISO 13485).
• Advanced skills with MS Office software are preferred.
• Able to lead change environment across multiple sites and customers globally.
• Able to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors, contractors, 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 at humanresources@sanisure.com and 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.