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Here at Human BioSciences, we work in a collaborative environment. Our management team has an open door policy and is readily accessible. We focus on how to make life better for the millions of patients who use our products. We work hard to ensure that the medical professionals who use our products can operate with complete confidence, and we are proud of our high standards and long tradition of excellence. We also believe in bringing a diverse talent to our ever growing and rapidly expanding business. Please contact us to learn about new, exciting and challenging opportunities that we currently offer.
Who we are looking for:
We are looking for self-motivated people who like being challenged and derive satisfaction from knowing that their efforts are making a difference in someone’s life. We value innovative thinkers and skilled individuals who are open to new opportunities.
If you have the right qualifications, please send us your resume at hr@humanbiosciences.com
Open Positions
Regulatory Affairs Specialist
Job Type – Full Time
DUTIES AND RESPONSIBILITIES:
• Design and manage Quality Control Department to include writing/updating quality manuals and monitoring performance of inspection functions
• Write and enforce quality manuals in compliance with GMP/QSR and ISO-13485, including design controls
• Manage FDA and ISO audits
• Apply for 510(k)s
• Provide training to staff to improve technical abilities and competence
• Distribute incoming, in-process, and final inspection materials
• Determine validity of customer complaints following CAPA regulations
• Organize and schedule inspections
• Act as a liaison for all matters relating to the quality of finished goods
• Maintain and report product conformance to engineering and customer specifications through inspection of raw material, work in process, and finished goods inventory.
• Review the production process for conformance to quality standards.
• Report/track any significant deviations from quality standards and recommending corrective action as necessary to management.
• Visit customer sites to determine quality requirements and gather feedback on current level of customer quality perception.
• Establish and present regular training sessions for inspection and manufacturing employees on quality issues
• Develop programs for each employee to perform quality control as a part of their operation
• Participate in new product development to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
• Visit material and component suppliers to review quality concerns and issues in an effort to minimize inspection requirements at the corporation’s business level
• Recommend and implement new testing equipment
• Perform other duties as required
REQUIREMENTS:
• BS in engineering or related field
• 5+ years of supervisory experience preferred
• Experience in medical device industry required (hardware, disposables)
• Experience with quality systems: writing manuals, conducting audits
• Knowledge of FDA / CFR compliance (QSR) and experience with ISO 13485 environment required
• Demonstrated experience developing and presenting training programs
• Excellent understanding of internal and external customer commitment
• Strong attention to detail, analytical and problem solving skills required
• Strong written and verbal communication skills including the ability to communicate and present technical information
• Ability to work independently in a hands on, fast paced, high growth, team environment with a sense of urgency
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