SBS - The Best Value in QMS software

Director vs. Manager - Roles in RA in a Medical Device Company

dr1vn

Involved In Discussions
#1
So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.
 
Elsmar Forum Sponsor
B

biboy2012

#2
Re: Director vs. Manager

So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.
I think Director and Manager are just job titles. The functions vary from organization to organization. Surely, they both manages and gives direction.
 
D

dkusleika

#3
Re: Director vs. Manager

Here's my opinion on the matter:
Manager: Anyone with at least one subordinate
Officer: Anyone who has been named an officer by the Board of Directors in their meeting minutes
Director: Anyone who has been appointed to the Board of Directors by the shareholders in their meeting minutes

I realize that not every company uses those definitions, but that's what I use.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#4
Re: Director vs. Manager

So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?
Biboy2012 is right when saying:

I think Director and Manager are just job titles. The functions vary from organization to organization. Surely, they both manages and gives direction.
however the other job titles for your organization may already be defined elsewhere, such as job description documents, or you can find this out from your Human Resources department.

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.
I believe the main objective of an org chart should be to show interactions and identify key responsibilities / authorites within your organizational structure. I would think that your sales people and project managers are "key" to the structure, since without them there would be no sales, no projects, etc.

Let's also not forget - ISO 13485 mandates that responsibilities and authorities be documented - they just don't tell you how. That is up to each organization to decide. An org chart is not the only way to document this - job description documents, statements of work, etc. are utilized often. Even with these, then maybe listing only the top two or three tiers in an org chart would be sufficient for a small to medium-sized organization.

I presume there are usually multiple items working in tandem to help address the requirements of 5.5.1, and there is no universal method that works for every company.

Brian :bigwave:
 

dr1vn

Involved In Discussions
#5
Re: Director vs. Manager

I believe the main objective of an org chart should be to show interactions and identify key responsibilities / authorites within your organizational structure. I would think that your sales people and project managers are "key" to the structure, since without them there would be no sales, no projects, etc.
:
That's an interesting point. I was initially thinking that just the top two or three levels would be sufficient/essential. But when you think of the words essential, then the lower levels are just as important.

Definitely some food for thought!
 

insect warfare

QA=Question Authority
Trusted Information Resource
#6
Re: Director vs. Manager

That's an interesting point. I was initially thinking that just the top two or three levels would be sufficient/essential. But when you think of the words essential, then the lower levels are just as important.

Definitely some food for thought!
I also think about who the audience is regarding an organization chart (whether a customer, an auditor, etc.). Thinking along those lines, it is usually a given assumption that those lower level people are in place and sustaining the system. But if you asked me to create an organization chart, I would jump in all the way and do my absolute best to categorize everyone who directly or indirectly affected product or service quality (it's just my style). From that point I would decide whether or not it would be beneficial to document the fact that we have other personnel as well (like janitorial and sanitation teams), though in an industry like medical devices they can be just as important in terms of process conformity. I would like to think that R & A for these job functions are defined elsewhere.

Keep in mind, I work in a manufacturing environment and not in medical devices. But I think my opinions on this topic could be translated across the board...
 
Thread starter Similar threads Forum Replies Date
R Quality Manager Reporting to Director of Manufacturing - Conflict of Interest? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
K VP, Director or Manager - Management By Walking Around (MBWA)? World News 27
A Organizational Chart - Manufacturing Manager report to Director of Quality ISO 13485:2016 - Medical Device Quality Management Systems 1
S Auditing General Manager/Manging Director General Auditing Discussions 4
J Interview with Director of Quality Career and Occupation Discussions 18
M Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature Medical Device and FDA Regulations and Standards News 0
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Manix The Toughest Decision I have ever had to make! Director or Quality Engineer Career and Occupation Discussions 16
V Company Director as Management Representative - TS 16949 Clause 5.5.2 IATF 16949 - Automotive Quality Systems Standard 7
R Company Director - Competency and Documented Job Description Requirements Document Control Systems, Procedures, Forms and Templates 2
C Interview with Quality Director and Manufacturing Director - Questions to Expect? Career and Occupation Discussions 14
1 Director of Reliability & Failure Analysis - Semiconductors Reliability Analysis - Predictions, Testing and Standards 0
O What skills are most important for a new Quality Manager Career and Occupation Discussions 4
F Need Quality Manager advice. Quality Manager and Management Related Issues 6
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
B Quality Manager Retiring IATF 16949 - Automotive Quality Systems Standard 5
S Quality manager considering data science Quality Manager and Management Related Issues 19
K IMDS Chemistry Manager RoHS, REACH, ELV, IMDS and Restricted Substances 0
C Quality Manager vs Warranty (service) Manager - Authorities & Responsibilities Customer Complaints 2
N ... and some have greatness thrust upon them - Training for novice QA manager ? Training - Internal, External, Online and Distance Learning 6
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F Position of Quality Manager - Can the organization's Quality Lead be shown as Quality Manager of the lab as well? ISO 17025 related Discussions 5
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
T New role Quality Manager IATF 16949, new company, advise how to get started IATF 16949 - Automotive Quality Systems Standard 2
CCaantley Stepping Down from my quality manager position soon After Work and Weekend Discussion Topics 18
M QMS Efficiency KPI as a Manager. IATF 16949 - Automotive Quality Systems Standard 7
Sam Lazzara Notified Body CE Project Manager - Worst job ever? EU Medical Device Regulations 6
A ISO 9001 Help - New Quality Manager - Upper Management Support Issues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
Kronos147 Quality Manager's Role in AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Certified Manager of Software Testing (CMST) Certification Exam Career and Occupation Discussions 4
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
J Configuration Manager's Duties - AS9110 or AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Q Supplier Accountable Manager Suspended - FAA 8130's while he is suspended? Federal Aviation Administration (FAA) Standards and Requirements 1
I Auto Industry Resume Template for a Quality Manager Career and Occupation Discussions 2
D Can the Plant Manager be our ISO Representative and an Internal Auditor? Internal Auditing 26
F Quality Manager - Conflict of interests in organisational structure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
S Quality Assurance Manager involvement in Management Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
L What are some SOPs that a Quality Manager should have? Document Control Systems, Procedures, Forms and Templates 6
P Leadership Standards - New job as Quality Manager Quality Manager and Management Related Issues 9
K New Quality Manager Role Quality Manager and Management Related Issues 13
C Salary for a CI Manager Career and Occupation Discussions 7
A Shall I apply for this job position (Quality Manager)? Career and Occupation Discussions 5
Q QA Manager Responsibilities Career and Occupation Discussions 9
M Manager IMS (9001, 14001, 18001) Position in Organisation Chart ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
V Manager wont take the lead ....Leadership wont provide clarity....what to do? Quality Manager and Management Related Issues 6
S R&D Documentation Manager Responsibilities Job Description Career and Occupation Discussions 1
J Lead Auditor and Quality Manager - Conflict of Interest? Career and Occupation Discussions 4

Similar threads

Top Bottom