Quality Mgt Systems Specialist
Company:
KARL STORZ Endoscopy-America, Inc.
(KSEA) Job Code:
12496 Pay Grade:
US-B15 Salary Range:
$35.
72 - $47.
09 Description KARL STORZ SE & Co.
KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
We are currently seeking a Quality Management Systems Specialist at KARL STORZ.
In this role you will primarily be responsible for leading and/or supporting efforts to meet the requirements of FDA/QSR systems, along with continued company growth.
Ensure that processes are compliant, effective, and efficient.
Leads the department when Quality Manager is absent.
REQUIREMENTS Bachelor's Degree Required.
5 or more years' experience in a Quality Control, Quality Assurance, Continuous Improvement, Process Control, or Manufacturing Engineering is Required.
Analytical, written/oral communication, PC, and organizational skills will be essential for successful completion of duties.
Experience in an FDA and/or ISO regulated Environment or Medical Devices desirable.
Experience with Six Sigma, Kaizen, 5S, or other improvement methodologies a plus.
Ability to read blueprints/schematics required.
Ability to write specifications a plus.
Experience with supplier evaluation and auditing.
RESPONSIBILITIES All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
Own various quality systems which includes responsibilities for writing and revising procedures, ensuring compliance, and establishing and monitoring performance metrics Work to ensure processes are compliant with FDA/QSR and ISO requirements.
Monitors quality system performance to compliance with regulations, standards, and the KARL STORZ quality management system.
Identify and lead projects to improve process efficiency and effectiveness.
Perform analysis, trending, and reporting of non-conformance, and complaint data.
Lead and/or assist with efforts to document processes for compliance with FDA/QSR and ISO requirements.
Manages the critical suppliers, develops supplier relationships, conducts supplier audits, and monitors and reports supplier performance to management.
Reports quality management system performance to management review and takes action items to improve quality management system performance.
Monitors and reports on training system to ensure training requirements are identified and personnel are trained in a timely manner.
Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
This incumbent will work in a typical office environment.
May need to spend significant amount of time in operational areas.
May need to lift up to 40 lbs.
Must be able to use phone and spend lengthy amount of time at computer creating/searching for information.
May require frequent travel, up to 25%.
Position requires good judgment and decision-making skills.
Position requires excellent attention to details.
Lead and participate in cross-departmental meetings.
Ability to establish strong cross functional relationships SAFETY:
Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all the Company's safety policies and rules.
Must be willing to report safety violations and potential safety violations to appropriate supervisory or management personnel.
QUALITY:
The incumbent in this position is generally responsible for following FDA/QSR guidelines as described in the procedures related to his/her specific job responsibilities.
#LI-AA1Pay Transparency The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Credentialing requirements at KARL STORZ KARL STORZ is committed to maintaining a safe work environment for our employees and customers.
Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment.
Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers.
During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Employee Benefits Program Overview for U.
S.
Locations Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too! 3 weeks vacation, 11 holidays plus paid sick time Up to 8 weeks of 100% paid company parental leave 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance We prepay your tuition up to $5,200 per year! - Tuition preimbursement Fitness reimbursement of up to $200 annually Employee referral program of up to $2,000 per hire And much more! Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
To include, maternal/paternal leave, adoption, and fostering of a child.
KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.
Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.
Employees must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.
To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.
KARL STORZ is also committed to providing reasonable accommodations during our recruitment process.
Should you need assistance or accommodation please email us at email protected .
Notice to Employment Agencies This recruitment assignment is being managed directly by KARL STORZ's Human Resources team.
Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.
Your respect for this process is appreciated.
KARL STORZ does not accept unsolicited Agency resumes.
Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.
Recommended Skills Analytical Attention To Detail Auditing Business Process Improvement Communication Continuous Quality Improvement (Cqi) Estimated Salary: $20 to $28 per hour based on qualifications.
KARL STORZ Endoscopy-America, Inc.
(KSEA) Job Code:
12496 Pay Grade:
US-B15 Salary Range:
$35.
72 - $47.
09 Description KARL STORZ SE & Co.
KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
We are currently seeking a Quality Management Systems Specialist at KARL STORZ.
In this role you will primarily be responsible for leading and/or supporting efforts to meet the requirements of FDA/QSR systems, along with continued company growth.
Ensure that processes are compliant, effective, and efficient.
Leads the department when Quality Manager is absent.
REQUIREMENTS Bachelor's Degree Required.
5 or more years' experience in a Quality Control, Quality Assurance, Continuous Improvement, Process Control, or Manufacturing Engineering is Required.
Analytical, written/oral communication, PC, and organizational skills will be essential for successful completion of duties.
Experience in an FDA and/or ISO regulated Environment or Medical Devices desirable.
Experience with Six Sigma, Kaizen, 5S, or other improvement methodologies a plus.
Ability to read blueprints/schematics required.
Ability to write specifications a plus.
Experience with supplier evaluation and auditing.
RESPONSIBILITIES All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
Own various quality systems which includes responsibilities for writing and revising procedures, ensuring compliance, and establishing and monitoring performance metrics Work to ensure processes are compliant with FDA/QSR and ISO requirements.
Monitors quality system performance to compliance with regulations, standards, and the KARL STORZ quality management system.
Identify and lead projects to improve process efficiency and effectiveness.
Perform analysis, trending, and reporting of non-conformance, and complaint data.
Lead and/or assist with efforts to document processes for compliance with FDA/QSR and ISO requirements.
Manages the critical suppliers, develops supplier relationships, conducts supplier audits, and monitors and reports supplier performance to management.
Reports quality management system performance to management review and takes action items to improve quality management system performance.
Monitors and reports on training system to ensure training requirements are identified and personnel are trained in a timely manner.
Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
This incumbent will work in a typical office environment.
May need to spend significant amount of time in operational areas.
May need to lift up to 40 lbs.
Must be able to use phone and spend lengthy amount of time at computer creating/searching for information.
May require frequent travel, up to 25%.
Position requires good judgment and decision-making skills.
Position requires excellent attention to details.
Lead and participate in cross-departmental meetings.
Ability to establish strong cross functional relationships SAFETY:
Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all the Company's safety policies and rules.
Must be willing to report safety violations and potential safety violations to appropriate supervisory or management personnel.
QUALITY:
The incumbent in this position is generally responsible for following FDA/QSR guidelines as described in the procedures related to his/her specific job responsibilities.
#LI-AA1Pay Transparency The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Credentialing requirements at KARL STORZ KARL STORZ is committed to maintaining a safe work environment for our employees and customers.
Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment.
Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers.
During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Employee Benefits Program Overview for U.
S.
Locations Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too! 3 weeks vacation, 11 holidays plus paid sick time Up to 8 weeks of 100% paid company parental leave 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance We prepay your tuition up to $5,200 per year! - Tuition preimbursement Fitness reimbursement of up to $200 annually Employee referral program of up to $2,000 per hire And much more! Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
To include, maternal/paternal leave, adoption, and fostering of a child.
KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.
Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.
Employees must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.
To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.
KARL STORZ is also committed to providing reasonable accommodations during our recruitment process.
Should you need assistance or accommodation please email us at email protected .
Notice to Employment Agencies This recruitment assignment is being managed directly by KARL STORZ's Human Resources team.
Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.
Your respect for this process is appreciated.
KARL STORZ does not accept unsolicited Agency resumes.
Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.
Recommended Skills Analytical Attention To Detail Auditing Business Process Improvement Communication Continuous Quality Improvement (Cqi) Estimated Salary: $20 to $28 per hour based on qualifications.
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