Manager, quality management, corporate compliance job description

Job Title: Manager, Global Quality & Compliance Audit

Location: Lakewood, CO

Type: Direct Hire, Full Time

Responsibilities:

+ Leads the Global Quality and Compliance Audit team to assure a compliant Quality Management System.

+ Supports Global Quality Systems Management and sites by applying an advanced level of understanding of international regulatory requirements and industry standards (e.g. FDA, ISO).

+ Supervises work and assigns tasks to the Global Quality and Compliance team.

+ Interprets regulations and standards into company policies and procedures, and owns the ongoing maintenance, execution, and improvement of the Global Audit Process.

+ Supports and improves various Quality System processes to maintain regulatory compliance

Must haves:

+ Bachelor of Science

+ Minimum 7 years of experience in Quality Assurance and /or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls.

+ Minimum 2 years of supervisory experience.

+ Preferred training in FDA Quality System Regulation and ISO 13485.

+ Hosted and/or led 10+ regulatory audits (e.g., MDSAP, FDA, Notified Body)

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Why Orthofix? Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision “To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."
Manager, Quality Compliance

How you'll make a difference?
As the Quality Compliance Manager you will be responsible for developing, defining, educating, advocating, and managing a superior compliance culture throughout Orthofix. Likewise, you must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. As the Quality Compliance Manager you will be responsible for ensuring Orthofix management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed.

What will your duties and responsibilities be?
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Management Responsibilities:
Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements. Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc.Monitors completion of post market activities, including complaint handling, to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals. Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance.Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements.Maintains CAPA process and verifies CAPA's are implemented as required to maintain suitability of both products and the Quality SystemMay provide training and/or training presentation documentation pertaining to FDA inspections, e.g., FDA hot topics, interaction with FDA officials, new regulatory approaches to inspections, etc.Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures.Monitor risk management process, including post-production risk, to ensure all regulatory and compliance obligations are satisfied.

What skills and experience will you need?
Bachelor's degree in engineering field or equivalent5 years' experience in medical device industry, with focus in quality engineering, quality systems, quality auditing, and/or regulatory compliance Knowledge of domestic and international medical device quality system laws, regulations and standards, such as 21CFR Part 820, ISO 13485:2016, ISO 14971, and ISO 11135.Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically. Must have Project planning and management capability.Computer knowledge: MS Word; MS Excel, MS Project, Visio, Outlook, Access, etc.Logical cognitive skills and ability to apply scientific methods and/or systems thinking Ability to identify variables affecting all aspects of quality Ability to meet deadlines and/or objectives as directed Must be able to interpret device law into workable, efficient and effective practices and procedures.Lead auditor certification highly desired

What skills and experience would be helpful?
Knowledge of internet investigation for new and updated standards Experience with global audits such as with Brazil and JapanCurrent with domestic regulatory thinking Experience in the spine and/or orthopedic industry Experience with medical device reporting and complaint management a strong plus

Will you have supervisory responsibilities?
Yes

What will the physical demands and work conditions be like?
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.Eyesight and hearing must be correctable to standard level.Travel required 10%, therefore must be able to utilize airplane, taxi and car.

Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Overview Manager - Corporate Facilities Management Ecumen is hiring a Manager - Corporate Facilities Management at our home office in Shoreview. We offer an extremely competitive benefits package that includes great 401K matching and health savings account (HSA) programs. You'll also enjoy the convenience and flexibility of working from home the majority of the time. Ecumen Overview

Ecumen is an industry leader dedicated to advocating for older adults by providing housing choices, compassionate healthcare, and innovative services. For 160 years Ecumen has cared for those in need. Now, as Minnesota's 8th largest senior living provider, we continue to advocate for those we serve.

Join a team where you can make a difference in advancing our mission to serve our older adults, while we commit to creating a place where everyone belongs.
Responsibilities
The Manager - Corporate Facilities Management position provides direction, training, guidance and support to our communities for all aspects of facility operations. The Manager - Corporate Facilities Management routinely communicates with site leadership teams, front-line team members, enterprise leaders, outside vendors and other partners. This position will also assist with driving compliance with Ecumen standards, systems and processes while helping maintain compliance with all regulatory standards.
Essential Job Responsibilities:
Supports the Corporate Facilities Director in day-to-day operations of the service line including processing accounts payable, negotiating, reviewing and maintaining contracts and agreements, maintaining the computerized work order management system, conducting investigations, organizing and conducting meetings.

Conducts site visits across the Ecumen portfolio to ensure compliance with regulatory standards, company policy and procedures, quality standards and preventative maintenance programs and attend regulatory site surveys and inspections as necessary.

Assists local management teams at each community with troubleshooting building-related issues, and acts as a subject matter expert and reliable source of information for industry-related topics.

Supports People Services' processes such as interviewing, hiring, training, coaching and development of Environmental Services leaders at the communities.
Provides necessary coverage and assistance to the communities as needed and assists with the opening of new communities.

Maintains a safe working environment for self and others by following all safety rules, regulations, policies and procedures of the facility as well as other regulatory guidelines from federal, state and local agencies including DOL, OSHA, CMS, EPA, DOT, MPCA, MDH, and MNDOLI.

Responsible for operating equipment in a safe manner by understanding all of the safety requirements for each piece of equipment, following all safety instructions and use guidelines from the manufacturer, following all recommendations for safe use of equipment from regulatory bodies, industry recommended standards and as outlined by company policy.

Other duties as assigned.


Qualifications
Manager - Corporate Facilities Management
Minimum Required Qualifications:
Education: Associates Degree in related field Experience: 5 years of facilities management experience Strong knowledge of building maintenance and asset management Strong knowledge of the regulatory environment Special Engineers Boiler's License Able to work independently, follow established processes Strong communication skills, both verbal and written Ability to prioritize and manage conflicting demands; strong sense of urgency Extremely organized, high attention to detail, accuracy and follow through Strong computer skills and familiarity with various software systems Previous experience managing third-party vendors Current valid driver's license and proof of vehicle insurance
Preferred Qualifications:
Bachelor's Degree in related field 10 years of relevant experience CHFM Certification or other related certification Healthcare Facilities Management Experience Safety and Emergency Management Experience Licensure/Certification: Certified HVAC Technician, EPA 608 Certification, Minnesota Electrical or Plumbing License


Equal Opportunity Employer
Ecumen is an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, familial status, disability, or status as a protected veteran.

Ensuring the safety and well-being of our residents, patients and staff is one of our highest priorities at Ecumen. To ensure we are complying with CMS guidelines, this position requires candidates to be fully vaccinated for COVID-19 or submit for an exemption request prior to starting employment.

We participate in E-Verify.