Quality And Ehs Specialist

Job Description:
The Quality and EHS Specialist is responsible for providing Quality and environmental, health, and safety management system expertise in the Össur Philadelphia location. The Specialist will be an active member of the global Quality & Regulatory team in Össur.

• Responsible for providing Environmental, Health, and Safety (EHS) Management System expertise and hands-on maintenance for the Philadelphia location of Össur, in alignment with the global Össur EHS System.
• Responsible for providing Quality Management System expertise and hands-on maintenance for the Philadelphia location of Össur, in alignment with the global Össur Quality Management System.

Responsibilities:

• Ensures regulatory compliance by assisting in implementation, management, and administration of the Össur Quality, Safety and Environmental Management Systems.
• Performs administrative tasks within the document control system, including routing for changes, updating documents, printing, distribution, and archiving. Maintains control of document originals and files. Maintains on-line documents and forms. Ensures correct revisions of documents are in all controlled locations.
• Generates new Quality, Safety and Environmental system procedures.
• Maintains direct contact with operations and technical services departments. Provides updates and changes to applicable documents.
• Maintain employee training documentation and assist in scheduling training on new or revised procedures.
• Responsible for record retention management.
• Liaison with regulatory bodies during external assessments. Provides auditing expertise and conducts and assists during internal audits and inspections.
• Assist with compiling and publishing Quality, Safety and Environmental data and reports.
• Supports the Customer Feedback process, as required.
• Maintains and updates Safety and Environmental program.
• Prepare and conduct weekly and monthly EHS meetings, Gemba walks, JSAs, as examples
• Conducts training relating to Quality, Safety and Environmental. Conducts in person training sessions, ranging from individual to large groups.
• Responsible for local compliance of the calibration and asset management program.
• Builds and maintains relationships by being a partner with management and employees.
• Support Employee Engagement initiatives.
• Representation in the recurring Global meetings such as Global Green Team meetings and Global Safety Meetings.
• As needed, support medium risk locations with Össur Quality, Safety and Environmental Management Systems.
• As needed, support creation and execution of non-conformity reports, CAPAs and Change controls.
• As needed, schedules reviews of NCs, Corrective/Preventive Actions and Change controls. Keeps records of actions and provides follow-up to initiators.
• Perform other duties as requested.

General:

• All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific.
• All training related to the quality management system is done in accordance to the Training Management Process.
• Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company's representative at all times.
• Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.

Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree, or an international equivalent in a related field.
• A minimum of 1 year experience working within the Quality Department of a medical device company.
• A minimum of 1 year experience working within an Environmental Health and Safety management system.
• Knowledge and understanding of ISO13485, ISO14001, OSHA, and related regulations.
• Previous experience in documentation, technical writing, or equivalent would be desired.
• Experience with Quality System Documentation and good documentation practices.
• Certified Quality Auditor or willingness to be certified.
• Must possess intermediate-level computer skills with Microsoft Office.
• Excellent communication skills and people skills for effectiveness in interdepartmental and multilevel communication as demonstrated from prior position(s) and employment interview.

Physical Requirements:
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.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
The US base hourly range for this full-time position is $29.00 - $33.00 + bonus + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Benefits we offer:

• Referral Bonuses
• Paid Sick and Vacation time
• We provide a flexible work environment to offer work/life balance
• 401(k) plan with company match
• Medical, dental, and vision insurance
• Wellness Program - Save up to 30% in your medical premiums
• Company Paid Life Insurance
• Affordable Short- & Long-Term Disability Insurance
• Affordable Accidental and Critical Illness Insurance
• 10 Paid holidays
• Give Back Program - Paid time off to Volunteer
• Tuition Reimbursement
• Annual Performance Reviews
• And Much More...

Össur is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Important Warning: Beware of fraudulent recruiters impersonating Össur. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. Össur will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official Össur website at https://www.ossur.com/global/about-ossur/careers-at-ossur