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1+ months

Sr. Manager QA/Complaints/Post Market Product

Kelly Services
San Diego, CA 92108
**Kelly is actively recruiting for Direct Hire Sr. Manager QA/Complaints/Post Market Product in San Diego, CA.**


Summary:

The Senior Manager manages the Complaints Handling, Post Market Surveillance and Vigilance processes and provides quality strategic oversight for Client product lines. This position is Quality leader in providing guidance and strategic development for new and existing Client products and is the main Quality contact for providing guidance on any issue associated with the Client product lines.


Primary responsibilities for role:


Provides Quality oversight over the management of customer complaints, post market surveillance, and medical vigilance for all Client products.


Ensures effective complaint management, appropriate complaint investigations are conducted, and effective trending is utilized to ensure safe and effective products remain

in the field.

Achieves on-time closure improvements in complaint management.

Trends data and reviews of same for possible systemic issues that may be impacting one or more Client products.

Reviews recommended CAPAs, as part of complaint closure process, and determine their appropriateness for the Root Cause(s) that were identified.

Performs final QA Approval for Complaints Records, post marker surveillance and medical vigilance reports for all Client products.

Provides strategic direction with external partners (Hologic and other third-party developers and manufacturers) regarding instrument, hardware, and software, changes and complaints.

Ensures appropriate issue escalation occurs related to any quality or compliance issues.

Provides the oversight and for inspectors during Health Authority audits/inspections, as necessary.

Serves as HA escort as required.

Provides support in other QA functions as needed.

Collaborates with Regional Quality Representatives to ensure efficient and effective resolution of complaints as they relate to Client products.

Leads the department in setting strategic objectives and deliverables for the customer complaints handling process.


Knowledge, Skills, and Abilities:

Knowledge of quality systems that ensure control of manufacturing processes in accordance with cGMP.

Knowledge of FDA and EU regulations, ISO requirements.

Skill in the use of computer systems for data compilation, managements, and analysis.

Experience with project management (problem solving and resolution) and general business principles.

Excellent written and interpersonal communication skills as well as strategic and conceptual thinking.

Experience with leading team or group projects.

Presentation and meeting organization/ facilitation skills required.

Ability to express view and opinions clearly, listen well, and accept conflicting points of view.

Team player and ability to multi-task.

Excellent analytical, organizational skills with a demonstrated ability to negotiate and resolve conflicts.


Education:

Bachelors Degree, in life or physical sciences, with experience in a clinical laboratory, diagnostic quality or technical area.


Experience:

At least 10 years related technical experience with significant QA, complaint handling, design control experience and/or pharmaceutical manufacturing.

Minimum of 5 years of supervisory / managerial experience


Occupational Demands:

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.



**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-10-28

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Sr. Manager QA/Complaints/Post Market Product

Kelly Services
San Diego, CA 92108

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