Quality Assurance Auditor

  • Anywhere

Company :
Medisafe International

Location :
Brooklyn Park, Minnesota

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

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Description :
Job Title: Quality Assurance Auditor Req ID: 21852 Job Category: Manufacturing Operations Country/Region: US State: MN City: Brooklyn Park Zip: 55445 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The Quality Assurance Analyst II position is applicable to contract laboratory, manufacturing (if applicable) and steam processing (if applicable). The position is responsible for facility Quality Management in coordination of day to day tasks, providing work direction to QA Technicians through provision of technical support and mentoring. This role supports compliance through maintenance and execution of critical processes, communication to Corporate Quality and Regulatory as well as within STERIS Laboratories faciliies. The Quality Assurance Analyst II leads under the direction of facility management continuous improvement to ensure adherence to Customer specifications and applicable Quality System standards and regulations. Duties * 40 %- Provides work direction for day to day activities, coaching, mentoring, and technical support to QA * Technicians.Tracks output, and provides support during employee absence or periods of high volume * 25%-Supports development, implementation and maintenance of Quality Systems including but not limited to CAPA, Document Control, Change Control and Risk Analysis * 15%- Particiaptes in and/or hosts facility external audits * 15%- Actively participates in departmental activities such as QA event investigation, Supplier Management, Change Control, Training, Internal Audits and resolution of audit findings * 5%- Communicates Quality department status to Corporate Quality and Regulatory and within the facility Education Degree * Bachelor’s Degree Required Experience * Microsoft Office: minimum 3 years * Related Experience: 3-5 years * Proven performance as a Laboratory Quality Analyst I or equivalent experience external to STERIS: 2+ years * Ability to effectively read, write and verbally communicate in English * Above average organizing, analyzing and a minimum of Level 4 math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans * Ability to adapt to changing responsibilities * Requires effective interpersonal skills as demonstrated through prior experience * Ability to work independently under minimal guidelines and supervision * Knowledge of regulations and standards, including, but not limited to, U.S. FDA device QSR, GMP and CGTP regulations, ISO 13485 medical device standard, and ISO 17025 laboratory standard * Ability to train and and assist in the development of staff within their facility * Willingness to demonstrate through daily activities a model of continuous quality system activity monitoring to ensure compliance to documented standards * Demonstrated ability to analyze data and performance metrics STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries. If you need assistance completing the application process, please call 1 . This contact information is for accommodation inquiries only and cannot be used to check application status. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity. The full affirmative action program, absent the data metrics required by 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours. Nearest Major Market: Minneapolis Job Segment: Audit, Medical, QA, Quality Assurance, Quality, Finance, Healthcare, Technology