ASQ 0502 JobSeekers

Are you ready to be part of a dynamic company leading innovation in human performance technology? Due to continuing growth, BTE has a junior-level Quality Assurance Specialist position available in the Quality department. With offices in the US and Canada, and a worldwide distributor base, BTE has been at the forefront of technology-assisted rehabilitation and physical abilities testing for over 30 years. Join our passionate, diverse group of talented professionals as we continue to reach new markets with industry leading healthcare products and services.

POSITION DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES)

The Quality Assurance Specialist position will perform duties to support the Quality Assurance program within a medical device manufacturing facility.

The ideal candidate for the Quality Assurance Specialist position will be experienced in handling a wide range of Quality Assurance and Regulatory Affairs-related tasks and will be able to work independently with minimal supervision. The candidate must be energetic, well-organized, flexible, and enjoy the administrative challenges of supporting an engineering and manufacturing facility.

A minimum of 2 years of Quality Assurance and/or Regulatory experience in the medical device industry is essential for this role.

1) Support the BTE Quality System including, but not limited to, process improvement, corrective and preventive action, complaint investigation and management, supplier quality management, materials management, training, and internal audit support;

2) Interact with all departments to co-ordinate preparation of and obtain necessary information for quality assurance activities;

3) Provide QC review of data and reports that are used throughout BTE to support management system operations;

4) Write or update Standard Operating Procedures (SOPs) and working guidelines, as needed;

5) Maintain and update quality and regulatory files and databases (both electronic and paper copy);

6) Assist Regulatory department with preparation of regulatory documentation, SOPs, submissions;

7) Provide support to quality, regulatory, production, clinical and engineering departments as needed;

Qualifications and Desired Skills

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1) Demonstrate working knowledge of current and applicable regulations e.g.: 21 CFR Part 820, FDA GMP, ISO 9001 and ISO 13485; Auditing experience preferred;

2) Appropriate full-time work experience is mandatory (no students or new graduates please);

3) Preference will be given to people who have recent experience in in the medical device industry;

4) Appropriate Regulatory or Quality certifications desirable;

5) Must have ability to read and interpret documents such as contracts, operating and maintenance instructions and procedure manuals;

6) Must have ability to read and comprehend simple instructions, short correspondence and memos; ability to write simple correspondence and/or reports; ability to respond to common inquiries or complaints from staff members, other department members and/ or contacts in the business community;

7) Experience with Microsoft Office including Outlook, Word, Excel, PowerPoint required;

BTE’s expertise is human physical performance evaluation and treatment. Our Rehabilitation Equipment provides advanced evidence-based physical therapy systems for clinics, hospitals, and private practices. BTE’s Workforce Solutions provides employers with superior processes and technology to enable employers to optimize productivity, through lower absenteeism/turnover, improved safety, reduced injuries and claims costs, and measurably increased performance. With BTE, people and companies achieve better outcomes.

Founded in 1979, BTE’s mission is providing the highest quality, innovative solutions in physical evaluation and rehabilitation, meeting and exceeding our customers’ needs. BTE cares about making a difference in people’s lives through facilitating better clinical outcomes and safer workplaces. We employ a diverse team of individuals dedicated to our mission, offering excellent salary and benefit packages, including health, dental and vision insurance, and 401K. If you are a driven individual, excited about contributing your talents to an organization that cares, apply for our Quality Assurance Specialist position today. Email your resume to jobs@btetech.com.

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