Intake Team Manager
Be part of something bigger at BD.
Here, you'll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers.
You'll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it's the right thing to do, but because our products impact people's quality of life.
Here, you'll put your compliance experience, high expectations and attention to detail to the very best use:
advancing the world of health.
At BD, you can make a true difference of one.
Job Type:
Full-Time Job Level:
Entry to Senior Travel:
Varies Salary:
Competitive Responsibilities Job Description SummaryThe Intake Team Lead reports directly to the Director, Post Market Quality Ops and acts as SME for both Complaints Management intake processes and IT applications.
Additionally, the Intake Team Lead will assist with daily/monthly/ad hoc metrics, ensuring appropriate scheduling, work allocation, timely responses to internal and external customer, and ongoing improvement activities.
The Intake Team Lead will also be responsible any additional responsibilities are delegated by Mgmt.
Job Description Primary Responsibilities and Duties o Run daily metrics, assigning complaints activities to RCC, ensuring appropriate scheduling, work allocation, timely responses to internal and external customero Monitor process performance to pro-actively assure RCC metrics are met based on customer needso Ensure that team members under direct supervision, follow establish procedures, practices, and policies for customer complainto Provide guidance and specialized knowledge for all operations supported by the RCC and/or Customer Quality Relations Teams.
o Facilitate team meetings, utilizing lean tools and acceptable quality levelso Lead RCC related Projectso Engage with Other Sites, Plants, and Business Units to Align Intake Complaint Handlingo Provide training to personnel involved complaint and quality metrics.
o Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.
o Maintains annually competencies through training and documentation of trainingo Maintain expert knowledge level of the compliant handling intake systemso Provide feedback to management for compliant process improvement opportunities (e.
g.
, complaints systems, final letters, escalations process, etc)o Provide training to RCC in complaints process and tools.
o Raise any escalated customer concerns to the next level of managemento Support and participate in site auditso Will interface with internal or 3rd party audits (e.
g.
FDA, Notified Body, etc.
)o Prepare team to always assure audit readiness.
o Develop and mentor personnel, including dedicated succession planning and contingency management.
Provide leadership directions/objectives, coach and develop associates.
May perform other duties as requiredMinimum Requirements Knowledge o High level of problem identification, analysis, and formulation of conceptual/technical and business solutionso Provide support to customer facing teamso Must be motivated, self-directed, and able to work with minimal supervisiono Ability to assess prioritieso Ability to take ownership, think independently and perform task with minimal supervision.
o Teamwork and collaborationo Influencing, coaching, and developing peopleo Developing and maintaining a diverse workforce and work environmento Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian RegulationsSkills o Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness.
o Proficiency in Excel and reporting applications.
o Ability to implement processes and systems.
o Excellent ability to apply a systematic and analytical approach to problem solving.
o Ability to create and present material, adjusting to the level of the audience (User, Manager, and Director level).
Education/Degree Bachelor's degree minimum, preferably in a Health Care, Nursing, Science, Technical or Engineering discipline or 5 yrs.
relative experience in lieu of a degree.
Certifications:
ASQ or equivalent preferred
Experience:
Three to Four years or more experience in the complaint handling desirable, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP and where applicable clinical and other laboratory functions.
For people management position, indicate years of experience 2 year's leadership experience in planning, developing, organizing, directing, managing, and evaluating personnelOther:
o Product knowledge - must have a working knowledge or product usage.
o Must have knowledge of product failure modeso Experience in health care setting desirable, e.
g.
, clinical labs, hospital, doctor's office, health care setting Primary Work LocationUSA TX - San Antonio Additional LocationsUSA UT - Sandy Work ShiftSalary:
$12.
65 - $27.
64.
Estimated Salary: $20 to $28 per hour based on qualifications.
Here, you'll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers.
You'll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it's the right thing to do, but because our products impact people's quality of life.
Here, you'll put your compliance experience, high expectations and attention to detail to the very best use:
advancing the world of health.
At BD, you can make a true difference of one.
Job Type:
Full-Time Job Level:
Entry to Senior Travel:
Varies Salary:
Competitive Responsibilities Job Description SummaryThe Intake Team Lead reports directly to the Director, Post Market Quality Ops and acts as SME for both Complaints Management intake processes and IT applications.
Additionally, the Intake Team Lead will assist with daily/monthly/ad hoc metrics, ensuring appropriate scheduling, work allocation, timely responses to internal and external customer, and ongoing improvement activities.
The Intake Team Lead will also be responsible any additional responsibilities are delegated by Mgmt.
Job Description Primary Responsibilities and Duties o Run daily metrics, assigning complaints activities to RCC, ensuring appropriate scheduling, work allocation, timely responses to internal and external customero Monitor process performance to pro-actively assure RCC metrics are met based on customer needso Ensure that team members under direct supervision, follow establish procedures, practices, and policies for customer complainto Provide guidance and specialized knowledge for all operations supported by the RCC and/or Customer Quality Relations Teams.
o Facilitate team meetings, utilizing lean tools and acceptable quality levelso Lead RCC related Projectso Engage with Other Sites, Plants, and Business Units to Align Intake Complaint Handlingo Provide training to personnel involved complaint and quality metrics.
o Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.
o Maintains annually competencies through training and documentation of trainingo Maintain expert knowledge level of the compliant handling intake systemso Provide feedback to management for compliant process improvement opportunities (e.
g.
, complaints systems, final letters, escalations process, etc)o Provide training to RCC in complaints process and tools.
o Raise any escalated customer concerns to the next level of managemento Support and participate in site auditso Will interface with internal or 3rd party audits (e.
g.
FDA, Notified Body, etc.
)o Prepare team to always assure audit readiness.
o Develop and mentor personnel, including dedicated succession planning and contingency management.
Provide leadership directions/objectives, coach and develop associates.
May perform other duties as requiredMinimum Requirements Knowledge o High level of problem identification, analysis, and formulation of conceptual/technical and business solutionso Provide support to customer facing teamso Must be motivated, self-directed, and able to work with minimal supervisiono Ability to assess prioritieso Ability to take ownership, think independently and perform task with minimal supervision.
o Teamwork and collaborationo Influencing, coaching, and developing peopleo Developing and maintaining a diverse workforce and work environmento Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian RegulationsSkills o Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness.
o Proficiency in Excel and reporting applications.
o Ability to implement processes and systems.
o Excellent ability to apply a systematic and analytical approach to problem solving.
o Ability to create and present material, adjusting to the level of the audience (User, Manager, and Director level).
Education/Degree Bachelor's degree minimum, preferably in a Health Care, Nursing, Science, Technical or Engineering discipline or 5 yrs.
relative experience in lieu of a degree.
Certifications:
ASQ or equivalent preferred
Experience:
Three to Four years or more experience in the complaint handling desirable, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP and where applicable clinical and other laboratory functions.
For people management position, indicate years of experience 2 year's leadership experience in planning, developing, organizing, directing, managing, and evaluating personnelOther:
o Product knowledge - must have a working knowledge or product usage.
o Must have knowledge of product failure modeso Experience in health care setting desirable, e.
g.
, clinical labs, hospital, doctor's office, health care setting Primary Work LocationUSA TX - San Antonio Additional LocationsUSA UT - Sandy Work ShiftSalary:
$12.
65 - $27.
64.
Estimated Salary: $20 to $28 per hour based on qualifications.
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