Team Lead-Compliance and Investigations

About Us:

Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities. Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market. For additional information, visit our website at www.

Poly-Med.com.

Our Team:

We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.

Employee Benefits and Information:

Health, Dental and vision coverage options Life, short and long term disability insurances 401(k) plan with employer matching Pay period is once a month.

Description:

This level consists of skilled and valuable Quality Assurance professionals capable of training and mentoring others. Their extensive knowledge, skills, and experience is so aligned with compliance and QMS needs that these individuals are capable to make some independent decisions for their project teams. The person in this role must possess an in-depth knowledge of all relevant quality techniques and have broad knowledge of commonly used concepts, practices, and procedures within quality assurance. They must work independently on tasks and projects, relying on experience, knowledge, and sound judgment to plan and accomplish goals, and lead the implementation and improvement of the PMI QMS. The Team Lead will be trusted to make independent decisions for their QA team, but know what decisions need to be elevated to the Quality Assurance Manager.

Responsibilities:

1. Responsible for PMI Compliance and Investigations functions including, but not limited to, compliance with applicable regulations/standards/guidance, eQMS maintenance, Quality Event management (Deviation process/approvals, Risk Assessment approvals, investigations, NCR process), CAPA process, and complaint process. 2. Participate in customer and regulatory audits as well as internal audits. 3. Build and upgrade quality processes and systems as required. Responsible for maintaining PMI ISO, cGMP, and GDP compliance in areas of responsibility. Maintain the file of applicable external documents and standards related to compliance. 4. Collect, summarize, and present metrics for the CRB, Metrics, and Management Review meetings. 5. Recommend and implement process improvements with the approval of Quality Assurance Manager. 6. Meet annual Quality objectives as set with management as well as any assigned Quality metrics. 7. Operate under pressure and still ensure standards are met while managing potentially detrimental effects to timeline and budget. 8. Capable of working independently from general supervision (skilled, self-motivated, and goal-oriented). 9. May be assigned as point of contact for relevant issues when manager is unavailable (responsible for escalating issues to manager). 10. Perform other responsibilities as assigned. Lead Responsibilities Lead a team 11. Responsible for leading the team day-to-day (providing clear guidance and direction on tasks). 12. Hire, train, coach, develop, encourage, discipline, reward, and promote staff as required and effectively direct the activities of self and staff. 13. Ensure entire staff is sufficiently knowledgeable, trained and experienced to perform their functions by improving and structuring the training of employees as well as supporting development of trained staff. 14. Positive feedback to highlight accomplishments and foster development. 15. Provide and deliver constructive feedback to highlight areas that need improvement. 16. Coordinate and consult with QA Manager and HR before engaging in disciplinary activities (i.e. warnings or terminations). 17. Does not wait until annual reviews so that expectations remain clear on a constant and consistent basis. 18. Draft and deliver annual reviews (coordinate and consult with QA Manager before delivering reviews). 19. Conduct Professional Development meetings with team members; coordinate and consult with QA Manager before offering potential professional development opportunities. 20. Provide recommendations to QA Manager of what the team needs to perform the job. 21. Advocate teamwork and build genuine and fun relationships. Decision Making 22. Make decisions in areas of ownership for low-risk items and smaller process implementations. Human Resources 23. Coordinate and approve team scheduling, time off requests, and overtime. 24. Perform HR-related responsibilities according to company standards, policies, and core values. 25. Collaborate with QA Manager on significant employee issues. 26. Drive Professional Development planning for the team. 27. Collaborate with QA Manager in setting performance goals, including 90-day goals and annual goals for employees. 28. Ensure adequate training and performance of personnel for executing their responsibilities in their functional area.

Minimum Requirements Education:

Associates Degree in a related field, plus 3-5 years in compliance and investigations

Preferable:

Associates Degree in a related field, plus 5-7 years in leadership Working Conditions at Poly-Med, Inc.: At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus. Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month. Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Job Type:

Full-time Pay:

$60,000.00 - $80,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible schedule Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Referral program Retirement plan Tuition reimbursement Vision insurance Application Question(s): Will you now or in the future require employer sponsorship for employment visa status (e.g., H-1B)?

Education:

Associate (Required)

Experience:

ISO 13485

1 year (Required) Compliance management: 3 years (Required) quality investigations: 3 years (Required) eQMS management: 1 year (Required)

CAPA :

3 years (Required) deviation process: 3 years (Required)

Work Location:

In person