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Regulatory Quality Specialist at Pride Mobility Products Corp

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Duryea, Pennsylvania





Job Description:

DESCRIPTION/JOB SUMMARY


To support Pride’s leadership team by providing decision-ready data that is utilized to advance our Global Product Integrity 


 


RESPONSIBILITIES/DUTIES


•Serve as co-primary Internal Auditor for all locations at Corporate, all locations in USA and Canada for Pride Mobility Products Corporation


•Conduct audits on Custom-Trade Partnership Against Terrorism (C-TPAT) at all locations in the USA and Canada


•Responsible for verification activities of all Corrective and Preventative Actions (CAPA’s) issued including researching data sources to ensure verification is accurate and correct


•Schedule and conduct Follow-Up Audits, where necessary


•To serve as the Quality Management System’s Document Control Coordinator


•Release and distribute newly developed, revised documents, or documents moved to obsolesces 


•Maintain and update Master Lists for Document Control


•Review all internal documents for Good Documentation Practices (GDP) and reject documents that are not complete


•Obtain and/or facilitate necessary signatures on documents


•Manage annual Aged Document Review, including notifications and/or CAPA’s where needed as well as resolution to issues


•Adhere to security and confidentiality regarding documents


•Create electronic copies of paper copies and archive and/or shred paper copies


•Provide system reports and updates to the Quality Management Representative


•Retrieve, mark, and store obsolete documents


•Ensure regulatory procedures and document changes are communicated to applicable personnel (Document Release)


•Maintain the Internal Audit Plan/Schedule, including any true-ups


•Issue Internal Audit Summary Reports including Certificates of Audit


•Issue any CAPA’s that may derive from the Internal Quality Audits, when needed


•Assist responsible parties in addressing CAPA’s that are derived from Internal Quality Audits


•Conduct routine trainings related to Quality System Documents, GDP, and External Document Control


•Maintain current electronic copies of all Quality System Documents referenced within the Supplier Reference Manual, including internal and/or external network locations


•Create and disseminate Supplier Corrective Action Requests (SCAR’s) in response to Supplier Audits submitted by Quality representatives utilizing databases, including hardcopy records


•Assist in closure of SCAR’s in response to Supplier Audits by means of updating database and hardcopy records


•Assist with Corrective Action Review Board activities, including the recording of validation activities within the database during meetings


•Establish and maintain National and International Standards used in the design and/or manufacture of components or finished medical devices


•Maintain training records for all Quality System Documents that affect employees of the Quality and Regulatory departments 


•Develop and achieve Simple, Measurable, Achievable, Relevant, and Time Bound (S.M.A.R.T.) goals and objectives that continuously advance the management of warranty/reliability data


•Make sure all National and International Standards are current and that departments are adhering to current revisions


•Ensure all safety and security rules are strictly observed and any accidents, incidents or injuries are promptly reported to management


•Attend the Annual C-TPAT Security Training


•Focus on continuous improvement, and consistently demonstrate good business judgment 


•Work effectively with all Pride departments to exceed internal and external expectations


•Pride retains the discretion to modify duties and/or assign other duties as necessary


 


REQUIRED SKILLS


•Must be a team player, friendly, self-motivated, professional, detail-oriented, and honest


 


Must have the ability to: 


•Multi-task, problem-solve, and prioritize in a fast-paced working environment


•Aggressively affect change and improvement at all levels of the organization


•Take initiative to get results without direct supervision


 


Must have: 


•Relentless drive to achieve advancement and continuous improvement


•Intermediate working knowledge of Microsoft Office Word, Excel, and PowerPoint


•Excellent web navigation skills 


•Excellent presentation, verbal and written communication skills


•Strong attention to detail


 


 


PREFERRED SKILLS


•Basic working knowledge of SQL preferred


•Advanced working knowledge of Microsoft Office Word, Excel, and PowerPoint preferred


 


REQUIRED EXPERIENCE


•At least 2 years of independent auditing experience in a regulated industry environment, OR 4 years of experience working in day to day operations of a regulated environment


 


PREFERRED EXPERIENCE


•Current or previous successful employment experience with Pride Mobility Products Corporation preferred


 


REQUIRED EDUCATION


•Bachelor’s Degree in Business, Health/Safety, Humanities, Social Science or a related field, OR an Associate Degree in Business, Health/Safety, Humanities, Social Science or a related field with at least 6 years of the required experience


 


PREFERRED EDUCATION


•Master’s Degree in a related field preferred


•American Society for Quality (ASQ) Certifications and/or training (Six Sigma, Auditing, Quality Engineer) preferred


 


DETAILS


•This job description is not intended to be all-inclusive


•In exceptional circumstances, some of the physical requirements of this position may be modified or eliminated as a reasonable accommodation for a person with a disability as defined by the Americans with Disabilities Act


 


Pride Mobility Products®/Quantum Rehab® is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected Veteran status, age, or any other characteristic protected by federal, state, or local law.


 


If you are a person with a disability, a disabled veteran, or require a reasonable accommodation or assistance in completing an application for employment, please contact our human resources department at 1-800-800-8586 x1440.