Quality System Specialist II

Job Title – Quality System Specialist II

Location – Sandy, UT

Duration – 12+ Months

Total Hours/week - 40.00
1st Shift

Client: Medical Device Company

Job Category: Quality

Level Of Experience: Mid-Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

• Work hours: 8-5
• Remote or onsite: Remote initially, onsite once clearance is give to return (COVID-19 related)
• 3 Must haves on the resume: Associates degree in nursing or science, examples of detailed oriented skills, knowledge of quality systems and medical device.
• Education requirements? Associates degree in nursing or science

Description:

MUST HAVE:

We need at least a bachelor level education. Experience in quality. Lab background a plus

• While there is a quality control background, It is mostly in document control which is not really what we do.
• Having experience with BD products and manufacturing is a plus but may not be enough to do the job we are asking for.

We are looking for:
• BS degreed in a science field, preferably biology or material science but we would also accept nursing or other science related areas.
• Some experience in a quality related job, not limited to document control. (Key words: IQ/OQ/PQ, validation, complaint handling, Change control)

Nice to have (but absolutely not deal breakers if they don’t have it) would include:
• Lab related processes (even if it is just college projects)

Quality System Specialist II

Job Description Summary
As directed by the Manager/ Sr. Manager Quality, the Quality System Specialist II (QSSII) is accountable for review of complaints for MDR reportability, completion of Medical Device Reports into the eMDR system and other projects as assigned.

Job Description

Responsibilities
• Maintains and resolves assigned tasks through the complaint database.
• Performs tasks, of moderate complexity, within planned schedules and timelines, supporting audits, participating on project teams, ensuring documentation compliance, handling processes and assigned tasks related to customer complaints and MDR’s
• Follows applicable Company / Unit procedures and may revise policies and procedures when asked upon.
• Develops solutions to assigned activities of limited scope (e.g. Document change, Complaint file entry, MDR documentation, etc.).
• Prepares reports and summaries as directed, including quantitative and qualitative analysis.
• Completes MDR DT’s.
• Completes MDR’s into the eMDR system.
• Knowledge of decisions regarding reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
• Closely monitors quality, completeness and timeliness of MDR DT completion. Reviews, tracks, trends, analyzes and reports on MDR data

Requirements
• Minimum Associates Degree in Nursing or Sciences.
• Understanding of quality science, clinical usage of devices, knowledge of quality systems, and strong performance management skills.
• Excellent communication skills
• Excellent team and interpersonal skills.
• Detail orientated.

Additional and Preferred Skills and Qualifications
• Bachelors degree in Science, Nursing, Mathematics or Engineering preferred..
• Knowledge in regulations for Medical Device Reporting (MDR) preferred.
• Duties are very complex in nature and pertain to the overall interaction of many Quality Systems
• Must be able to multitask and prioritize effectively to meet business goals and departmental objectives