enVista
Document Control Specialist
enVista, Sturtevant, Wisconsin, United States, 53177
Job Description:
This
Document Control Specialist
will be responsible for ensuring that all procedures and engineering change requests (ECR), document change requests (DCR) and other documents managed by Document Control are accurately completed, entered, updated, and tracked in the system. This position is also responsible for ensuring that MasterControl and the processes used in MasterControl are maintained and supported. This person will be required to work on-site full time.
Essential Duties and Responsibilities:MasterControl System Administrator (Electronic Document and Training Models).Manage and maintains the electronic document and training models.Route documents for review and approval in MasterControl.Trains end-users to access, revise, and sign-off on task to support document and training models.Provides periodic reports for on-time training.Maintains paper distribution as needed.Runs reports to support the system, including master list for document modules.Device Master Records: Manage and maintains accurate DMR for compliance to the FDA 21CFR 820 regulation and ISO 13485 and other applicable regulationsEngineering and Research and Development Support.Supports Engineering and Research and Development staff.Routes and tracks DCR-ECR in MasterControl for traceability.Member of the AOA Internal Audit team.Drives Continuous Improvement using Envista Business System (EBS).Supports Non-conformance and Corrective Action and Preventive Actions (CAPAs).Quality Control System:
Supports 3rd Party AuditsSupports training needs as defined by management.Supports special projects as defined by management.
Job Requirements:
MINIMUM REQUIREMENTS:
Associate's or Bachelor's degree preferred4+ experience working as an Office Administrative Assistant or similar role where they have had experience with controlling documentation (i.e. SOPs, Work Instructions, Design Documents, etc.)Knowledge of Microsoft Office Suite including MS Excel (Intermediate)PREFERRED REQUIREMENTS:
Experience with MasterControl as Site System AdministratorAbility to navigate between different computer programsExperience with Adobe Editor and Visio (Intermediate)Knowledge of technical writingKnowledge of FDA 21, CFR 820, ISO 13485Experience with internal auditingSupport of Corrective and Preventative Action (CAPAs)Supporting 3rd party auditsCRITICAL SKILLS:
Language Ability : Ability to read, write and comprehend English. Must have excellent verbal, interpersonal, and written communication skills.Math Ability:
ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.Reasoning Ability : ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.Self-Starter- ability to work independently is a must.Results Oriented:
must be team player with the drive to achieve results and goals in the short and long term.Customer Focused:
Must drive to discover and meet the needs of internal and external customers.High Intellect:
Must be conceptual, strategic, and able to probe into specifics when necessary. Must be a problem solver using analytical skills based on facts and intuition to draw conclusions. Has ability to prioritize on relevant and critical issues. Is an independent thinker with an open mind.Adaptable to Change:
must have the ability to work effectively in a demanding, and fast-pace environment with uncertainly and ambiguity. Can make pragmatic decisions in a timely fashion and especially when there is not a clear "right way."Technical Excellence:
Attention to detail. Have depth and breadth of job-related expertise and the motivation to use and expand one's technical knowledge.
Supervisory Responsibilities : No supervisory responsibilities for this position.
Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
$52,800 - $79,100
Operating Company:Ormco
Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
This
Document Control Specialist
will be responsible for ensuring that all procedures and engineering change requests (ECR), document change requests (DCR) and other documents managed by Document Control are accurately completed, entered, updated, and tracked in the system. This position is also responsible for ensuring that MasterControl and the processes used in MasterControl are maintained and supported. This person will be required to work on-site full time.
Essential Duties and Responsibilities:MasterControl System Administrator (Electronic Document and Training Models).Manage and maintains the electronic document and training models.Route documents for review and approval in MasterControl.Trains end-users to access, revise, and sign-off on task to support document and training models.Provides periodic reports for on-time training.Maintains paper distribution as needed.Runs reports to support the system, including master list for document modules.Device Master Records: Manage and maintains accurate DMR for compliance to the FDA 21CFR 820 regulation and ISO 13485 and other applicable regulationsEngineering and Research and Development Support.Supports Engineering and Research and Development staff.Routes and tracks DCR-ECR in MasterControl for traceability.Member of the AOA Internal Audit team.Drives Continuous Improvement using Envista Business System (EBS).Supports Non-conformance and Corrective Action and Preventive Actions (CAPAs).Quality Control System:
Supports 3rd Party AuditsSupports training needs as defined by management.Supports special projects as defined by management.
Job Requirements:
MINIMUM REQUIREMENTS:
Associate's or Bachelor's degree preferred4+ experience working as an Office Administrative Assistant or similar role where they have had experience with controlling documentation (i.e. SOPs, Work Instructions, Design Documents, etc.)Knowledge of Microsoft Office Suite including MS Excel (Intermediate)PREFERRED REQUIREMENTS:
Experience with MasterControl as Site System AdministratorAbility to navigate between different computer programsExperience with Adobe Editor and Visio (Intermediate)Knowledge of technical writingKnowledge of FDA 21, CFR 820, ISO 13485Experience with internal auditingSupport of Corrective and Preventative Action (CAPAs)Supporting 3rd party auditsCRITICAL SKILLS:
Language Ability : Ability to read, write and comprehend English. Must have excellent verbal, interpersonal, and written communication skills.Math Ability:
ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.Reasoning Ability : ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.Self-Starter- ability to work independently is a must.Results Oriented:
must be team player with the drive to achieve results and goals in the short and long term.Customer Focused:
Must drive to discover and meet the needs of internal and external customers.High Intellect:
Must be conceptual, strategic, and able to probe into specifics when necessary. Must be a problem solver using analytical skills based on facts and intuition to draw conclusions. Has ability to prioritize on relevant and critical issues. Is an independent thinker with an open mind.Adaptable to Change:
must have the ability to work effectively in a demanding, and fast-pace environment with uncertainly and ambiguity. Can make pragmatic decisions in a timely fashion and especially when there is not a clear "right way."Technical Excellence:
Attention to detail. Have depth and breadth of job-related expertise and the motivation to use and expand one's technical knowledge.
Supervisory Responsibilities : No supervisory responsibilities for this position.
Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
$52,800 - $79,100
Operating Company:Ormco
Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.