게시판 그룹 > 상담게시판_취업 > Three Positions Open - Chemical Lab Technician and Logistics Associate - Entry Level , Regulatory Affair Specialist

작성일 : 21-03-16 10:15

Three Positions Open - Chemical Lab Technician and Logistics Associate - Entry Level , Regulatory Affair Specialist

글쓴이 : Dentca, Inc.

1. Chemical Lab Technician - Entry Level

Job description:

This person is a laboratory technician to work on the 3D printing operation, 3D printable resin development and denture fabrication. He/she works with and report to Principal Scientist. He/she produces 3D printed dental products or other developed products, prepares specimens for several tests and conducts analysis of such materials for material development and production. He/she is in charge of production of 3D printed dental products, testing and maintenance of 3D printer, technical support to customer service on 3D printing, shipping of final products and sample products. He/she also collaborates with his/her team member and other department to perform his/her tasks. He/she must have a basic knowledge of chemistry and be familiar with a laboratory setting and chemicals. We will provide the job-related basic training.

Responsibilities:

· Timely generates the 3D printed dentures according to the schedule.

· Maintains and tests various 3D printers and organize the 3D printing areas.

· Produces 3D printed dental products and samples.

· Prepares test specimens for chemical and/or physical laboratory testing.

· Handles and manages various 3D printable materials for 3D printed dental products.

· Provides technical supports and training to customers on 3D printed denture.

· Clearly and orderly records all observations of data according to company QMS SOPs.

· Reports test results in a clear and concise manner to supervisor.

· Maintains and organizes the final products and sample stock.

· Timely performs shipping and packaging works of final products and samples.

· Performs general housekeeping, as needed including ordering of materials and reagents.

· Cleans and Organizes lab and testing machines.

· Provides weekly and monthly reports to supervisor.

· Other duties as assigned.

Qualifications:

· Basic knowledge of chemical and/or polymer background

· 0+ years related work experience with Associate degree or BA degree in chemical or related filed.

· Excellent interpersonal, written and verbal communication skills.

· Basic computer skills including Microsoft Office with proficiency with Word, Excel, and PowerPoint.

· Requires the ability to lift up to 40 pounds

Position Details:

· Salary: DOE

· Position: Full-time, In-house

· Benefits: Medical, Dental, Paid Vacation and holidays

· Sponsorship provided for qualified person

2. Logisitics Associate -Entry Level

Job Description:
The person will assist the production team leader to do a label printing, packaging, and labeling on the final products, and shipping arrange according to the orders and control the inventory.

The ideal candidate has a accurate and good housekeeping skills of the shipment record and can perform to timely pack it and arrange the shipment. The person will be involved with medical device production and assist the production technician and team leader. We are looking for the enthusiastic person and will provide the job-related training (Chemical Engineer also welcome)

Role and Responsibilities
Inventory

Ensure all packing supplies are available and stocked at all times; proactively communicate when supplies need to be ordered
Responsible for making sure all orders are packed perfectly and neatly.
Maintain clean, organized and efficient workspaces.
Maintain records of shipment and BOLs.
Manage inventory levels of safety stock of inventory in the raw materials and packaging area, restocking in a timely manner as needed.
Re-organization of dental tray inventory at on-site and offsite warehouse.
Provide monthly inventory counts to the Finance Team though inventory location preparation, inventory counts, documentation of movements, and other tasks as requested.
Ensure packaging and labeling processes of final medical device products.
Responsible for maintaining a safe work environment and complying with company safety protocols.
Assist the works related with medical device production.
Develop and maintain packaging and shipping work flows to manage the final production process, Document and update the work instruction and procedures.
Perform other duties and tasks as assigned from time to time by supervisor or team leader.
Be able to life heavy boxes almost daily (80 pounds)
Logistics

Pick and pack orders.
Generate the labeling and necessary packaging labels for the final products.
Arrange the shipment according to the orders internally and domestically.
Create the packing slips and prepare the required documents for the medical devices shipment.
Work with Production team leader to maintain the stock level of raw material, packaging material and final product.
Document and record of the shipment.
Update the order record when the order shipped.
Requirements and Qualifications

Regular, reliable and punctual attendance.
Strong problem-solving skills, with the ability to manage and prioritize multiple projects.
Exceptional accuracy, organizational skills, and attention to detail.
Ability to multi-task and adjust priorities to meet deadlines on short notice in an intertruptive environment.
Ability to work independently with minimal supervision.
Strong interpersonal skills and demonstrated ability to build and maintain relationships at all levels of an organization.
Excellent oral and written communication skills.
Ability to demonstrate discretion, good judgment, tactfulness and diplomacy.
Team-player and can-do attitude, flexible and cheerful in a rapid-growth, high-change environment.
Demonstrated knowledge of MS Office, including Word and Excel.
Experience in retail, picking/packing, and shipping is preferred
Experience working with USPS, DHL, Fedex and UPS
While performing the duties of this job, the employee will need to sit, stand, hear, listen and perform other actions typical of an production environment. The employee may also have to lift and/or move up to 80 pounds.
Preferred basic knowledge of chemical and/or chemical mixing.
Position Details:

Salary: DOE
Position: Full-time, In-house
Benefits: Medical, Dental, Paid vacation and holidays
Sponsorship provided for qualified person

3. Regulatory Affair Specialist

POSITION SUMMARY:

This person is a regulatory affair associate to provide the support for the regulatory matters on the Dental devices, in order to ensure efficient and compliant business processes and environment. He/she works with and report to top management. He/she may execute tasks and exercise influence generally at the middle management level. He/she will assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

ESSENTIAL DUTIES:

Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Australia, Brazil, India, China, Japan, South Korea, and other countries.
Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products
Coordinate and prepare document packages for regulatory submissions to the US, EU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, CE Mark, Health Canada].
Responsible in the preparation and compilation of domestic and international product registration submissions. This includes, but is not limited to Pre-Market Notifications, 510ks, CE technical files and international dossiers (such as Canada, China, Brazil, Australia, Japan Russia, India, etc.).
Represent Regulatory Affairs on change controls and provide regulatory assessment.
Review and approve marketing communication materials
Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII, MDR and ISO 13485, Canadian CMDCAS, etc.
Monitor regulatory and legislative environment and provide impact assessment
Provide information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.
Support external audits (FDA, notified Body, international regulators, etc.) as requested
Participate, as assigned, as a CAPA owner, team member, or “task” owner.
Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes.
Direct communication with regulatory authorities regarding company’s regulatory filings.
Remain current on developments in field(s) of expertise, regulatory requirements and industry trends.
Create and update departmental standard operating procedures (SOPs).
Lead post-market management including complaint handling, medical device reporting, and recall.
REQUIREMENTS:

Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline required.
2 years of experience in Medical devices regulatory submissions required.
Experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.
PREFERRED SKILLS/EXPERIENCE:

Experience with FDA, Health Canada and international regulators is strongly preferred.
Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.
Ability to clearly communicate and write reports and business correspondence in English.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.
Experience in supporting international registrations.
Knowledge of US and international medical devices regulations, guidelines, and policies.
Expert at compiling medical device documents into clear, easy-to-understand submissions packages.
Expert at writing, reviewing and editing technical documents.
Highly effective at working with cross-functional teams from diverse disciplines and culture.
Must be able to negotiate internally and externally with regulatory agencies.
Identify, communicate and solve regulatory issues with project teams and management.
Strong organizational skills.
Ability to read, understand and retain extensive working knowledge of procedures and company documents.
Excellent MS-Office Applications.
Able to produce positive results with a strong sense of urgency and ability to multi-task.
Strong interpersonal and presentation skills.
Knowledge of Quality System Requirements and Standards.
Additional Information:

· Salary: DOE

· Position: Full-time, In-house

· Benefits: Medical, Dental, Paid Vacation and holidays

· Sponsorship provided for qualified person