Medical Device Support Analyst Jobs

1 -2 year experience in medical device industry background

Proactive and results-oriented who can work independently and as part of a team to effectively manage assignments and support customer queues.

Must have excellent verbal and written communication skills.

Good interpersonal skills with the ability to react quickly, accurately, and remain calm under pressure.

1- 2 years related experience providing technical support

Experience using mobile devices such as cell phone, laptop and tablet to perform work activities

Data analysis and problem-solving skills are necessary to identify and countermeasure common failure issues.

Robust documentation and strict adherence to approved procedures are a requirement in the highly regulated work environment.

Evaluate documentation of service records against expected standard across a complex product portfolio.

Initiate remediation of service records and/or generate customer complaints when gaps are revealed.

Utilize MS Excel analytics to provide service leadership with reporting as well as trending of failures including recommendations for improvement.

Communicate with Customer Technical Specialists, Field Service & Application Engineers to gather more data when needed.

Communication is IMP and Time Management skills

• Proven analytical experience and critical thinking skills are required.

• Working knowledge of various claim processing principles, documentation requirements, and processing systems is required.

Contracts Analyst with Bio-Pharma OR Medical Device Experience

3+ years of related experience in the biotech, pharmaceutical, healthcare industry.

• Basic knowledge of Model N and/or Validata is preferred but not required.

• Bachelor’s degree in a science curriculum or equivalent combination of education/experience.

8. Participation in validation/qualification activities

• FDA regulated industry (food, pharmaceutical or medical device) experience is required.

• Minimum of 2years relevant experience required.

• Strong work ethic and organizational skills.

1. Provide support to Quality Control Department by performingtesting for materials and products.

Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion

Performs Data Entry into GxP Regulated Systems as required

Bachelor’s degree and 3-5 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background.

Strong written and verbal communication skills

The ideal candidate will have experience with design history file, FDA 21 CFR part 820 and ISO-13845.

The responsibilities of this position may include, but are not limited to, the following:

Knowledge of Medical Devices and Regulatory Requirements

Participate in local vendor management meetings, promoting continuous improvement

Thorough knowledge of and current certification in international and domestic air transport regulations.

plays a key role in the ordering, management, and collection of worldwide field medical devices.

3-4 years of strong Global Shipping and Logistics experience is Required, preferably from another CRO or pharma company

Knowledge of Customs and International Shipping Regulations/Restrictions for Import/Export

Other Required Skills & Abilities:

Experience in working with seniors

Articulate, with good written and speaking skills

The candidate must be able to complete a minimum of 10 device integrations per day once oriented

The hire will be provided with a UCSD lap top, Cisco head set and home tech kit (keyboard, mouse)

The candidate would be required to complete client Learning modules as required