Job Description

Job Title: Complaints Investigation Technical Investigator – (JP10377)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Complaints Trending
Duration: 1+ years (with likely extensions)
Notes: Hybrid in Thousand Oaks, CA. Needs to come onsite weekly and be a local candidate.

Posting Date: 06/01/22

3 Key Consulting is hiring a Complaints Investigation Technical Investigator for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of client’s mission to serve patients, the Complaints Trending and Investigation group at client is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will conduct technical investigations of Level 2 and 3 complaints associated with product design and/or usability issues, as well as conduct trend and consolidated investigations using data analytics. S/he will be responsible for the validity and integrity of the investigations and reports, including the data and its statistical analysis. S/he will also participate and/or lead in cross functional ideation of design solutions. The complaints investigation technical investigator maintains close interaction with the engineering and quality management functions to contribute to product improvement and management reporting. Additionally, s/he will support the implementation and validation of the equipment in the investigation lab.

Basic Qualifications:

Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR
Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience; OR
Associate’s degree and 8 years of related medical/biopharma development or Operations experience;

Preferred Qualifications:

Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience with statistics and statistical analysis
Demonstrated competency in root cause analysis methodology
Experience with protocol and report writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented team leader

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:

MUST have experience with root cause analysis and technical investigation

Compliant experience (similar industry preferred)

Good oral and written communications skills

Detail oriented

Technical degree

Day to Day Responsibilities:

Lead root cause analysis of mechanical and/or electromechanical products to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree Analysis
Perform trend and consolidated investigations. Accountable for validity of statistical assessment of data to identify trends, as well as ownership of monthly reports
Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
Develop and perform relational data analytics in support of investigations
Deliver reports and investigations on time per client and regulatory requirements
Understand customer / patient use of client’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for client’s packaged and/or distributed products
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms

Employee Value Proposition:
Exposure to different departments.

Red Flags:

See must have skills
Job hoping
No technical experience
No experience with investigation/ technical investigation

Interview process:

Phone screening followed by in-person interview.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry

Unknown

Company Size

1-10 employees

Headquarters

Simi Valley, CA

Year Founded

2009

Website

3keyconsulting.com

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