- Ensure TMC is effectively monitoring for all new and revised external regulations and standards.
- Partner with Quality Compliance Process Manager to establish time-bound product plans to conduct gap assessments and remediation activities within the required timeframes.
- Provide Regulation and Standard Management assistance to the organization as required.
- Assist management on development, implementation, and maintenance of Quality Performance Indicators for Standards management and dashboard to monitor product/process compliance to the most up-to-date requirements.
- Collaborate with Post-Market Surveillance team to establish a robust process for overseeing the management of all post-market sustaining activities required to maintain global market access.
- Monitor to ensure input from cross-functional teams required for PMSP, PSUR, PMCF, CEP, and CERs is being provided in accordance with the established schedule.
- Escalate issues impacting the timeliness of the post-market requirements and external standard deliverables to management.
- Coach, mentor, and cross-train less experienced staff on the skills and competency required to successfully perform their responsibilities.
- Support TMC sites and subsidiaries on compliance and quality related issues.
- Participate on product design teams and verify compliance to applicable regulations and external standards.
- Coordinate input from various stakeholders, such as Medical Affairs and PMS, required to draft Health Hazards Evaluations and ensure information provided to the Critical Action Committee meeting is complete and accurate.
- Partner with cross-functional teams on projects (NPD, Sustaining, Acquisition) as a Compliance SME, including the role of:
- Independent reviewer on design control projects to ensure compliance with internal regulations and external standards.
- Drive Quality System or product enhancement projects associated with regulatory changes.
- Review and draft proposed changes to Quality System procedures/forms as required to maintain compliance and improve overall efficiency and effectiveness.
- Perform other job-related tasks as assigned.
- Practical experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements, preferably for medical devices.
- Solid analytical and critical thinking skills.
- Demonstrated ability to effectively communicate with all levels of the organization including Executive Leadership.
- Ability to provide clear direction to others.
- Strong interpersonal skills with the capability to influence cross functional collaboration.
- Effective proofreading and writing skills.
- Strong organizational and prioritization skills.
- Ability to navigate the grey.
- Demonstrated decision-making skills including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
- Independent decision-making on routine business tasks.
- Proven ability to multi-task and deliver timely results.
- Proficient computer knowledge (MS Office)
- Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
- . degree or equivalent in Scientific or Engineering discipline required.
- Master's degree in science or engineering preferred.
- Minimum of 5 to 8 years overall experience in a regulated industry, specifically medical device/diagnostic, pharmaceutical with focus on Quality System Regulations
-
Sr Quality Compliance Engineer
1 week ago
Terumo Medical Corporation Elkton, United StatesJob Summary · The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutic ...
-
Quality Assurance Specialist
1 week ago
The Spear Group Elkton, United StatesThe Spear Group Specialist Quality Assurance, with guidance from the Quality Assurance Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketpla ...
-
Quality Leader
3 days ago
W.L. Gore & Associates Elkton, United States**About the Role**:We are looking for a Quality Leader to ensure that quality standards are met and to be accountable for the overall performance of the quality processes within the plant. A significant focus for this leader will be developing the quality team, improving quality ...
-
Planner - Stormwater
1 week ago
Cecil County Government Elkton, United States**Planner 1** · - **Position Summary**_ · - **Position Responsibilities**_ · 1. Prepare the County's MS4 Annual Report. · 2. Track public outreach and education events. · 3. Coordinate the County's Watershed Stewards Academy. · 4. Develop and maintain databases and Geographic Inf ...
-
Strategic Customer Support
1 week ago
W.L. Gore & Associates Elkton, United States**About the Role**:Gore's Performance Solutions Division is committed to delivering breakthrough performance solutions for customers' complex product and process challenges in several key markets and industries including aerospace, automotive, mobile electronics and semiconductor ...
-
Operations Engineer Tank Farm BGH
1 week ago
Stellar Innovations Valley Head, United StatesYour Responsibilities · Strong focus on HSSE and ensuring compliance with all relevant regulations in the areas of occupational safety and process safety · Responsible for ensuring availability, integrity, and preservation of assets at the OMV Refinery Burghausen in the Tank Farm ...
-
Environmental Engineering Co-op
1 week ago
UniFirst Wilmington, United StatesUniFirst Corporation, a leader in uniform service, is seeking an energetic Environmental Engineering Co-Op to join the Environmental, Health and Safety team based at its corporate headquarters in Wilmington, MA. · This individual will be involved various activities, including: · ...
-
Lab Assistant
1 week ago
Actalent Kennett Square, United States Full timeDescription: · • Performs all room start-up and close-out activities (including: assigning tasks, staging materials, ensures equipment is set-up, demonstrating process/training team, & reconciliation). · • Performs all packaging and labelling activities as a needed. · • Explains ...
-
Lab Assistant- Pharmaceutical Production
4 days ago
Actalent Kennett Square, United States Full timeDescription: · • Performs all room start-up and close-out activities (including: assigning tasks, staging materials, ensures equipment is set-up, demonstrating process/training team, & reconciliation). · • Performs all packaging and labelling activities as a needed. · • Explains ...
-
Chief Scientist
1 week ago
NetSEA Technologies Aberdeen Proving Ground, United StatesClearance Level: US Citizen with active Top Secret clearance preferred · Location: Aberdeen Proving Grounds, MD · Hours: Monday - Friday, normal business hours · Travel: Up to 25% · Roles/Responsibilities: · As a Chief Scientist, you will leverage your expertise to: · - Execute e ...
-
Rf Experimentalist
1 week ago
SURVICE Engineering Company Aberdeen Proving Ground, United States**Join Us in Making a Difference in the Lives of Those Defending Our Nation** · **Why SURVICE?** · Come join the SURVICE Engineering mission to protect, enhance, and enable those who defend the United States. Since 1981, we have supported the DoD community, as well as Homeland Se ...
-
Administrative Assistant
1 week ago
NetSEA Technologies Aberdeen Proving Ground, United StatesClearance Level: US Citizen with active Secret clearance preferred · Location: Aberdeen Proving Grounds, MD · Hours: Monday - Friday, normal business hours · Travel: Up to 25% · Roles/Responsibilities: · In the role of Administrative Assistant, you will utilize your expertise to: ...
-
Distribution Area Lead
6 days ago
AstraZeneca Wilmington, United StatesAre you ready to adapt and innovate at pace? AstraZeneca is seeking a Distribution Area lead for NAM for North America. This position leads a team responsible for Distribution and Warehousing for the US market. As a leader, you will manage relationships with AstraZeneca's third-p ...
-
Maintenance & Reliability Superintendent
18 hours ago
Phillips 66 Wilmington, United StatesPhillips 66 & YOU - Together we can fuel the future · The Maintenance and Reliability Superintendent, Instrumentation, manages the Instrumentation and Analyzer resources at the Los Angeles Refinery, Wilmington and Carson Plants, including engineers, supervisors, specialists, craf ...
-
Construction Inspector
3 days ago
Kleinfelder Inc New Castle, United States**Job Description**: · Century Engineering, LLC, a Kleinfelder Company, is a multidisciplinary professional services firm offering a broad range of services to include consulting, engineering, environmental, planning, design, and construction services. With a dedicated staff of o ...
-
Plant Services Manager
5 days ago
Campbell Soup Company Downingtown, United StatesSince 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innovations. It serves as inspiration and foundation for our future success. We're proud to be stewards of amazing brands that people trust. We foster a culture of b ...
-
Accounts Receivable Specialist
1 week ago
Watson-Marlow Fluid Technology Solutions Wilmington, United States**Location: WMFTS Recruiting Locations** · **Benefits: Enhanced Carer/Paternity Leave, Additional Holiday, EAP and more** · We're currently seeking a Accounts Receivable Specialist to join us. You'll join a dynamic team of engineers, sales people, marketers, administrators, desig ...
-
Erosion & Sediment Control Inspector
1 week ago
Brudis & Associates, Inc. Bel Air, United States**Erosion & Sediment Control Inspector** · **BRUDIS & ASSOCIATES, INC.** (BAI) is a multidiscipline engineering firm providing consulting services to public and private sector clients in the Maryland, Virginia, and District of Columbia region. Since 1992, BAI has provided compreh ...
-
Assistant Project Manager
1 week ago
Tri-M Group Kennett Square, United StatesHere at The Tri-M Group, LLC we are an employee owned company placing our employees first, knowing that highly trained, skilled, and compensated workforce can better serve our customers, our families and our communities. We've built a reputation for delivering quality and profess ...
-
Ports & Harbors Team Lead - Chadds Ford, Pa
1 week ago
Bowman Consulting Group, Ltd. Chadds Ford, United StatesOverview: · Bowman has an opportunity for a Ports & Harbors Team Lead to join our team in Chadds Ford, PA. At Bowman, we believe in creating opportunities for aspiring people to thrive and achieve ambitious goals. That's why a career at Bowman is more than a job. It is an opportu ...
Sr. Quality Compliance Engineer - Elkton, United States - Terumo Medical Corporation
Description
Job Summary
The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance to all global regulations and external standards for medical devices, combination medical device/pharmaceutical, and software products through collaborative partnerships and out-reach with cross-functional departments. This includes but is not limited to: FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation 745/2017, and MDSAP Country requirements.
Job Details/Responsibilities
Knowledge, Skills and Abilities (KSA)
Qualifications/ Background Experiences