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| Job Category : | Engineer |
| Company Name: | Nucleus Biologics |
| Position Name: | Quality Engineer |
| Location : | Nucleus Biologics in San Diego, CA 92127 |
| Job Description : | Unfortunately, we are unable to offer work visa sponsorship at this time. JOB SUMMARY: The Senior Quality Engineer supports the Quality System for Nucleus Biologics. This position leads corrective action and continuous improvement activities in collaboration with the company’s quality vision and strategy. This person will utilize and improve existing processes and build new process to comply with GxP and ISO 13485:2016. This individual will also be responsible for building a culture of continuous improvement and developing all personnel to create professional growth opportunities. This individual will become an important member of the Quality team in a well-funded and growing company. They is to be a proven performer who is a deliberate and intelligent performer and has experience in the biologics or cell culture Quality field.II. RESPONSIBILITIES: The incumbent may be asked to perform other functions related activities in addition to the below mentioned responsibilities as reasonably required by the business needs.a) Provides execution and guidance for one or more critical/high-risk quality systems (Change Control, Design Change Control, Corrective and Preventive Actions, Non-Conformance, Complaints, Risk Management, V&V, Auditing, Failure Investigation), ensures compliance to quality systems and supports implementation as needed to deliver business resultsb) Identifies need for, develops, and executes continuous improvement plans for assigned systemsc) Direct experience of quality management within a manufacturing environment is highly desirable, demonstrating an understanding of major quality management processes and practices such as GMP, statistical quality control, product testing and internal quality auditingd) Ensures that established manufacturing inspection, sampling, and statistical process control procedures are followed as applicablee) Leads or supports assessments of required facilities, functions and suppliers to provide an independent and expert viewpoint. Uses the assessment process to build capability, drive continuous improvementf) May lead or support the implementation of medium to large business initiativesThis position offers potential for flexible work from home options.Have Fun and contribute to a winning cultureIII. REQUIREMENTS: EDUCATION:Undergraduate degree required. MS/PhD in a technical field (e.g. biology) is a plus.KNOWLEDGE AND EXPERIENCE:· Requires 5-10 years of experience in the Biotech or Pharma Quality industry.SKILLS AND ABILITIES:· Thorough understanding of ISO 13485:2016· Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships with persons contacted in the course of performing assigned duties including subordinates, Company management and outside business associates· Strong attention to detail· Ability to exercise independent judgment consistent with Company guidelines· Strong process mindsetPROBLEM SOLVING AND DECISION MAKING:· Develops solutions to a variety of complex problems; ensures solutions are consistent with organization objectivesPHYSICAL REQUIREMENTS:· Ability to hear and speak to employees and outside business associates on the phone and in person.· Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)SUPERVISORY RESPONSIBILITY:· May direct exempt and nonexempt employees; make hire, termination, promotion, and merit decisions.TRAVEL REQUIREMENTS:· Travel to and from Nucleus Biologics offices or customer/vendor locations both domestically and internationallyNOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.Job Type: Full-timePay: $70,000.00 – $90,000.00 per yearBenefits:401(k)Dental insuranceHealth insuranceHealth savings accountPaid time offReferral programVision insuranceSchedule:8 hour shiftMonday to FridayAbility to commute/relocate:San Diego, CA 92127: Reliably commute or planning to relocate before starting work (Preferred)Application Question(s):Do you have a thorough understanding of ISO 13485:2016Education:Bachelor’s (Preferred)Experience:Bio/Pharma: 5 years (Required)Work Location: One location |
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