Orchestra BioMed, Inc.
Document Control Specialist
Orchestra BioMed, Inc., New Hope, Pennsylvania, United States, 18938
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.
Job Summary
The QMS Document Control Specialist is responsible for managing and maintaining the company's Quality Management System documentation to ensure compliance with regulatory standards for medical devices. This role involves coordinating document revisions, approvals, distributions, and storage while ensuring all documentation meets internal and external audit requirements. T
his is an office-based position located in either our New Hope, PA or Ft. Lauderdale, FL
Role and Responsibilities – Including but not limited to:
Document Management:
Create, review, revise, and maintain QMS documents, including Standard Operating Procedures (SOPs), Work Instructions, Forms, and Records.
Ensure all documentation is controlled, accurate, current, and compliant with ISO 13485, FDA regulations, and other applicable standards.
Coordinate the approval process for new and revised documents, ensuring timely review and authorization.
Documentation Systems:
Manage electronic document management systems (EDMS) to store and control QMS documents.
Implement and maintain document control procedures and processes.
Maintain and secure hard copy record files
Audit and Compliance:
Prepare for and support internal and external audits by ensuring documentation is readily available and compliant.
Address audit findings related to document control and implement corrective actions as necessary.
Support Lead auditor in conducting internal audits and documenting audit results.
Training and Support:
Provide training and support to employees on document control processes and the use of the document management system and GDP requirements.
Assist with the development and delivery of QMS training materials.
Maintain and create job codes and training curriculum as needed.
Continuous Improvement:
Identify opportunities for improvement in document control processes and implement best practices.
Collaborate with cross-functional teams to ensure alignment and compliance with QMS requirements.
Implement new eQMS modules as needed.
Assist in trending quality data as needed.
Other duties may be assigned based on business needs aligning with skill set
Occasional travel may be required
A current and ongoing US work authorization is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. The level of this position will be based on the final candidate’s qualifications.
Qualifications – Knowledge & Skills:
Bachelor’s degree in Quality Management, Life Sciences, Engineering, or a related field.
Certified Quality Auditor (CQA) or other relevant certifications strongly preferred
Minimum of 3 years of experience in document control within the medical device industry or a regulated environment.
Understanding of document change management and FDA quality systems.
Knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
Strong attention to detail and organizational skills.
Proficiency in using electronic document management systems (EDMS) and Microsoft Office Suite.
Excellent communication and interpersonal skills
Ability to work independently and as part of a team.
Experience with quality management software (e.g., MasterControl, Veeva, or similar).
Familiarity with other regulatory standards (e.g., MDR, MDSAP).
Must possess a high level of attention to detail.
Why Join Orchestra BioMed
In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.
Our Vision
To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.
Our Mission
We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.
Our Values
We care
about patients, physicians, partners, and each other
We are creative
, open-minded, adaptable and think “outside the box”
We are driven
to always do our best and we do not give up
We deliver
and are accountable to promised results
EQUAL OPPORTUNITY EMPLOYER
Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Important notice to employment businesses/agencies
Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided.
In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.
Job Summary
The QMS Document Control Specialist is responsible for managing and maintaining the company's Quality Management System documentation to ensure compliance with regulatory standards for medical devices. This role involves coordinating document revisions, approvals, distributions, and storage while ensuring all documentation meets internal and external audit requirements. T
his is an office-based position located in either our New Hope, PA or Ft. Lauderdale, FL
Role and Responsibilities – Including but not limited to:
Document Management:
Create, review, revise, and maintain QMS documents, including Standard Operating Procedures (SOPs), Work Instructions, Forms, and Records.
Ensure all documentation is controlled, accurate, current, and compliant with ISO 13485, FDA regulations, and other applicable standards.
Coordinate the approval process for new and revised documents, ensuring timely review and authorization.
Documentation Systems:
Manage electronic document management systems (EDMS) to store and control QMS documents.
Implement and maintain document control procedures and processes.
Maintain and secure hard copy record files
Audit and Compliance:
Prepare for and support internal and external audits by ensuring documentation is readily available and compliant.
Address audit findings related to document control and implement corrective actions as necessary.
Support Lead auditor in conducting internal audits and documenting audit results.
Training and Support:
Provide training and support to employees on document control processes and the use of the document management system and GDP requirements.
Assist with the development and delivery of QMS training materials.
Maintain and create job codes and training curriculum as needed.
Continuous Improvement:
Identify opportunities for improvement in document control processes and implement best practices.
Collaborate with cross-functional teams to ensure alignment and compliance with QMS requirements.
Implement new eQMS modules as needed.
Assist in trending quality data as needed.
Other duties may be assigned based on business needs aligning with skill set
Occasional travel may be required
A current and ongoing US work authorization is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. The level of this position will be based on the final candidate’s qualifications.
Qualifications – Knowledge & Skills:
Bachelor’s degree in Quality Management, Life Sciences, Engineering, or a related field.
Certified Quality Auditor (CQA) or other relevant certifications strongly preferred
Minimum of 3 years of experience in document control within the medical device industry or a regulated environment.
Understanding of document change management and FDA quality systems.
Knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
Strong attention to detail and organizational skills.
Proficiency in using electronic document management systems (EDMS) and Microsoft Office Suite.
Excellent communication and interpersonal skills
Ability to work independently and as part of a team.
Experience with quality management software (e.g., MasterControl, Veeva, or similar).
Familiarity with other regulatory standards (e.g., MDR, MDSAP).
Must possess a high level of attention to detail.
Why Join Orchestra BioMed
In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.
Our Vision
To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.
Our Mission
We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.
Our Values
We care
about patients, physicians, partners, and each other
We are creative
, open-minded, adaptable and think “outside the box”
We are driven
to always do our best and we do not give up
We deliver
and are accountable to promised results
EQUAL OPPORTUNITY EMPLOYER
Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Important notice to employment businesses/agencies
Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided.
In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.