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Quality Assurance Specialist
2 months ago
Your primary responsibilities will include maintaining the effectiveness of our Quality Management System (QMS), ensuring the implementation of QMS processes, and managing key quality assurance processes such as document control, records control, and non-conforming material.
You will also be responsible for investigating customer complaints and product returns, assisting in managing new and existing product and site regulatory registrations, and inspecting received material and outgoing customer orders.
In addition, you will analyze quality data and generate reports, support sales efforts by providing regulatory and quality data as required, and contribute to the development of our quality management systems.
To be successful in this role, you will need to have a strong understanding of quality management concepts, including ISO 13485:2016, ISO 14971:2012, 21 CFR 820, and EU MDR. You will also need to have excellent analytical and problem-solving skills, as well as the ability to work in a fast-paced, high-energy environment.
If you are a detail-oriented, collaborative team player with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
**Key Responsibilities:**
* Maintain compliance of ISO 13485 Quality Management System (QMS) to US FDA, Health Canada, European MDD and other global regulatory requirements
* Ensure effective implementation of QMS processes
* Manage key quality assurance processes: document control, records control, non-conforming material, corrective and preventive action, etc.
* Assist QA Manager in internal audit program and external audits and inspections
* Investigate customer complaints and product returns
* Assist in managing new and existing product and site regulatory registrations
* Inspect received material and outgoing customer orders
* Analyze quality data and generate reports
* Support sales efforts by providing regulatory and quality data as required
**Requirements:**
* Post-secondary degree in science, engineering, business or equivalent
* 1-2 years of experience in a Quality Assurance Role in medical devices/pharma or other regulated industry
* Experience running core Quality processes including Corrective and Preventive Actions, Non-conformances, Document Control
* Solid understanding of Quality Management concepts
* In-depth knowledge of all relevant Quality Management Standards including ISO 13485:2016, ISO 14971:2012, 21 CFR 820, EU MDR, Health Canada Regulations
* Excellent analytical and problem-solving skills
* Self-motivated, detail-oriented, responsible and timely team-player
* Excellent written, verbal, presentation and collaboration skills
* Comfortable in a fast-paced, high energy, customer-focused start-up environment
**Nice to Have:**
* Familiar with process improvement concepts such as DMAIC
* Prior experience in statistical methods and the use of statistical software such as SAS JMP, Minitab, R
* Prior experience working in a SaMD manufacturing environment operating using Agile development methodology
**About SHOEBOX Ltd.:**
WS Audiology (WSA) is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.
At SHOEBOX Ltd., your contribution will have a meaningful impact every single day. On top of that, you\u2019ll be an integral part of an innovative team, working with the latest tools and technologies, pushing the boundaries of what the Quality Assurance function can do, and collaborating with colleagues who are passionate about their crafts.
We also take time to celebrate our successes, enjoy lunchtimes together, and genuinely like and care about one another.
We offer competitive salaries and benefits, real work-life balance, flexible hours, and a discretionary wellness benefit. SHOEBOX Ltd. will provide you with a MacBook Air with memory to spare.
We invite enthusiastic and qualified applicants to submit their resumes here.
We thank all applicants; however, only those selected for an interview will be contacted.
**Equal Opportunity Employer:**
SHOEBOX Ltd. is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We welcome and encourage applications from people with disabilities. Accommodations are available.
**Job ID:**
#J-18808-Ljbffr
