Job Description

job summary:
***ON-SITE IN ROCHESTER NY, MUST HAVE BACHELORS***

• Candidates are preferred to have a bachelor\'s degree in a related field, worked in a regulated environment, have technical writing, or PM experience. Someone who\'s worked in healthcare (specifically medical device sector), or a laboratory would also be preferred.

Day to Day: The PM will communicate daily between client, manufacturers, and engineers to generate test protocols and data sheets. They would also be responsible for the Technical Writing portion of the position, ie: review final reports / raw data for the various programs (cleaning, sterilization efficacy, packaging, bio/materials compatibility and repetitive cycling).

Benefits: Health (HSA offered), dental, 401k (3% contribution annually), and competititve PTO

location: Rochester, New York
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 8am to 4pm
education: Bachelors

responsibilities:
Project Managers communicate with clients to generate protocols, datasheets, and

review final reports / raw data for the various program\'s (cleaning, sterilization efficacy, packaging, bio/materials compatibility and repetitive cycling). Project Managers perform higher-level activities and tasks within their service program and when required, including the following;

• Work directly with clients when generating test protocols and create raw

data sheets

• Perform technical reviews raw data and final reports

• Answer client questions and hold regular conference calls

• Provide updates to clients on study progress

• Provide follow-up support to clients after issuance of final reports

• Request specific test materials and supplies for the laboratory to complete

client studies

• Assist with OOS investigations, and perform CAR\'s, PAR\'s, or CAPA

investigations and Reports, communicating with clients

• Review AAMI and ISO standards during revisions and comment on them as

well as participate in applicable standards meetings

• May validate new processes, procedures or equipment in the laboratory

• May write IQ/OQ/PQ validations

• Any other duties as needed to meet the needs of the business and our

clients
qualifications:

• Experience level: Entry Level
• Minimum 2 years of experience

• Education: Bachelors

skills: * Project Management

• Technical Writing
• Laboratory
• ISO (1 year of experience is required)
• FDA
• GMP
• Excel (1 year of experience is required)
• Customer Relationship
• Administrative

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate\'s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Randstad